DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the claim(s) under 35 USC 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments. Examiner agrees that Beyar in view of Feldman alone does not teach the amended subject matter of the independent claims, however Lampropoulos teaches the limitations.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Beyar (US 6,726,675) in view of Feldman (US 2008/0004530) in view of Lampropoulos (US 2008/0167542).
Re claims 1, 7, and 13, Beyar teaches a system comprising:
one or more controls configured to be operated by a user (control console 34; user-interface peripheral device 38; tactile control unit 40);
a control system to move a percutaneous intervention device within a vasculature (control console 34; see at least col. 4, ln. 60-61, for guiding catheter fed into blood vessel); and
a controller (control console 34; controller 56) to:
detect operation of the one or more controls to control movement of a percutaneous intervention device (see at least col. 5, ln 34-36, for control unit 40 provides directional and speed instructions to propelling device 38);
instruct the control system to move a tip of the percutaneous intervention device (see at least col. 6, ln. 12-20, for propelling device advances catheter through vessel);
determine a distance moved by the tip of the percutaneous intervention device (implied as the distance is displayed as cited below); and
display the determined distance to the user (see at least col. 5, ln. 16-27, for displaying on monitors 36 data such as an indication of the distance that the catheter has traveled).
Beyar is not explicit regarding the specifics of:
detect a first operation of the one or more controls to control movement of a percutaneous intervention device;
in response to the first operation, instruct the control system to move a tip of the percutaneous intervention device into alignment with a first end of a structure within a vasculature;
detect a second operation of the one or more controls to control movement of the percutaneous intervention device;
in response to the second operation, instruct the system to move the tip of the percutaneous intervention device into alignment with a second end of the structure while executing the distance measurement to determine a distance moved by the tip of the percutaneous intervention device from alignment with the first end of the structure to alignment with the second end of the structure.
However, Feldman teaches guiding the tip of a catheter inserted into a blood vessel by a controller to point P and retracting to point O in order to capture and measure a region of interest (see at least Figs. 2-3 and 8 and para. 28 and 35).
It would have been obvious to one of ordinary skill in the art to modify the invention of Beyar with the features of Feldman because it allows for the measurement of a particular region of interest of a blood vessel.
Modified Beyar is silent regarding detect activation of a measurement mode to initiate a distance measurement while the tip of the percutaneous device is disposed at the first end of the structure.
However, Lampropoulos teaches using activation buttons to display a desired measurement after placing a tube member into a vein and the displaying the distance traveled as the tube member is moved (see at least para. 44).
It would have been obvious to one of ordinary skill in the art to modify modified Beyar with the features of Lampropoulos because it allows for a user to specify when to start and stop measuring distance.
Re claims 2, 8, and 14, modified Beyar is silent regarding the controller further configured to: detect completion of the measurement mode while the tip of the percutaneous intervention device is aligned with the second end of the structure, wherein the distance moved by the tip of the percutaneous intervention device from alignment with the first end of the structure to alignment with the second end of the structure is determined in response to detection of the completion of the measurement mode, and wherein determination of the distance comprises determination of the distance moved by the tip of the percutaneous intervention device from alignment with the first end of the structure to alignment with the second end of the structure while the measurement mode was active.
However, Lampropoulos teaches placing a tube member into a vein, using activation buttons to display a desired measurement, and the displaying the distance traveled as the tube member is moved (see at least para. 44). Therefore, the total distance traveled would be the distance measured from activation until tube movement has ended, equivalent to completion of the measurement mode.
It would have been obvious to one of ordinary skill in the art to modify modified Beyar with the features of Lampropoulos because it allows for a user to specify when to start and stop measuring distance.
Re claims 3, 9, and 15, Beyar is not explicit regarding wherein the first end of the structure is a distal end of the structure, and the control system is configured to move the tip of the percutaneous intervention device from the first end of the structure to the second end of the structure by retracting the percutaneous intervention device from the vasculature.
However, Feldman further teaches guiding the tip of a catheter inserted into a blood vessel by a controller to point P and retracting to point O in order to capture and measure a region of interest (see at least Figs. 2-3 and 8 and para. 28 and 35).
It would have been obvious to one of ordinary skill in the art to modify the invention of Beyar with the features of Feldman because it allows for the measurement of a particular region of interest of a blood vessel.
Re claims 4, 10, and 16, Beyar further teaches wherein the control system is configured to move the tip of the percutaneous intervention device in at least two degrees of freedom (see at least col. 6, ln. 47-55, for longitudinal and rotational movement).
Re claims 5, 11, and 17, Beyar further teaches wherein the percutaneous intervention device comprises one of a catheter guide wire, a working catheter, a guide catheter, a stent, and an angioplasty balloon, and wherein the at least two degrees of freedom include axial movement and rotation (catheter 26 and guide wire 46; see at least col. 6, ln. 47-55, for longitudinal and rotational movement).
Re claims 6, 12, and 18, Beyar is not explicit regarding wherein the first end of the structure is a distal end of the structure, and the control system is configured to move the tip of the percutaneous intervention device from the first end of the structure to the second end of the structure by retracting the percutaneous intervention device from the vasculature.
However, Feldman further teaches guiding the tip of a catheter inserted into a blood vessel to point P and retracting to point O in order to capture and measure a region of interest (see at least Figs. 2-3 and 8 and para. 28 and 35).
It would have been obvious to one of ordinary skill in the art to modify the invention of Beyar with the features of Feldman because it allows for the measurement of a particular region of interest of a blood vessel.
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- 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 8,694,157 in view of Lampropoulos (US 2008/0167542).
Re claims 1, 4, 6-7, 10, 12-13, 16, and 18, claim 1 of patent ‘157 is silent regarding detect activation of a measurement mode to initiate a distance measurement while the tip of the percutaneous device is disposed at the first end of the structure.
However, Lampropoulos teaches using activation buttons to display a desired measurement after placing a tube member into a vein and the displaying the distance traveled as the tube member is moved (see at least para. 44).
It would have been obvious to one of ordinary skill in the art to modify patent ‘157 with the features of Lampropoulos because it allows for a user to specify when to start and stop measuring distance.
Re claims 2, 8, and 14, claim 1 of patent ‘157 is silent regarding the controller further configured to: detect completion of the measurement mode while the tip of the percutaneous intervention device is aligned with the second end of the structure, wherein the distance moved by the tip of the percutaneous intervention device from alignment with the first end of the structure to alignment with the second end of the structure is determined in response to detection of the completion of the measurement mode, and wherein determination of the distance comprises determination of the distance moved by the tip of the percutaneous intervention device from alignment with the first end of the structure to alignment with the second end of the structure while the measurement mode was active.
However, Lampropoulos teaches placing a tube member into a vein, using activation buttons to display a desired measurement, and the displaying the distance traveled as the tube member is moved (see at least para. 44). Therefore, the total distance traveled would be the distance measured from activation until tube movement has ended, equivalent to completion of the measurement mode.
It would have been obvious to one of ordinary skill in the art to modify patent ‘157 with the features of Lampropoulos because it allows for a user to specify when to start and stop measuring distance.
Re claims 3, 9, and 15, modified claim 1 of patent ‘157 teaches all the additional limitations.
Re claims 5, 11, and 17, claim 2 of patent ‘157 in view of modified claim 1 of patent ‘157 teaches all the additional limitations.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 9,814,534 in view of Lampropoulos (US 2008/0167542).
Re claims 1, 6-7, 12-13, and 18, claim 1 of patent ‘534 is silent regarding detect activation of a measurement mode to initiate a distance measurement while the tip of the percutaneous device is disposed at the first end of the structure.
However, Lampropoulos teaches using activation buttons to display a desired measurement after placing a tube member into a vein and the displaying the distance traveled as the tube member is moved (see at least para. 44).
It would have been obvious to one of ordinary skill in the art to modify patent ‘534 with the features of Lampropoulos because it allows for a user to specify when to start and stop measuring distance.
Re claims 2, 8, and 14, claim 1 of patent ‘534 is silent regarding the controller further configured to: detect completion of the measurement mode while the tip of the percutaneous intervention device is aligned with the second end of the structure, wherein the distance moved by the tip of the percutaneous intervention device from alignment with the first end of the structure to alignment with the second end of the structure is determined in response to detection of the completion of the measurement mode, and wherein determination of the distance comprises determination of the distance moved by the tip of the percutaneous intervention device from alignment with the first end of the structure to alignment with the second end of the structure while the measurement mode was active.
However, Lampropoulos teaches placing a tube member into a vein, using activation buttons to display a desired measurement, and the displaying the distance traveled as the tube member is moved (see at least para. 44). Therefore, the total distance traveled would be the distance measured from activation until tube movement has ended, equivalent to completion of the measurement mode.
It would have been obvious to one of ordinary skill in the art to modify patent ‘534 with the features of Lampropoulos because it allows for a user to specify when to start and stop measuring distance.
Re claims 3, 9, and 15, modified claim 1 of patent ‘534 teaches all the additional limitations.
Re claims 4, 10, and 16, claim 3 of patent ‘534 in view of modified claim 1 of patent ‘534 teaches all the additional limitations.
Re claims 5, 11, and 17, claim 2 of patent ‘534 in combination with claim 3 of patent ‘534 teach the limitations of the claim. It would have been obvious to one of ordinary skill in the art to modify the system of claim 2 with the features of claim 3 because axial movement provides for both movement along blood vessels and rotation provides steering within blood vessels for said percutaneous intervention devices.
Claims 1, 4-7, 10-13, and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 10,779,895. Although the claims at issue are not identical, they are not patentably distinct from each other because while the claim language is not identical the patent claims infringe upon the instant claims. The controller claims and method claims are directed towards similar subject matter as the system claims and are thus rejected under similar rationale.
Instant claims
Corresponding patent claims
System claims 13, 16, and 18; controller claims 1, 4, and 6; method claims 7, 10, and 12
1
System claim 17; controller claim 5; method claim 11
2
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 10,779,895 in view of Lampropoulos (US 2008/0167542).
Re claims 1, 4, 6-7, 10, 12-13, 16, and 18, claim 1 of patent ‘895 is silent regarding detect activation of a measurement mode to initiate a distance measurement while the tip of the percutaneous device is disposed at the first end of the structure.
However, Lampropoulos teaches using activation buttons to display a desired measurement after placing a tube member into a vein and the displaying the distance traveled as the tube member is moved (see at least para. 44).
It would have been obvious to one of ordinary skill in the art to modify patent ‘895 with the features of Lampropoulos because it allows for a user to specify when to start and stop measuring distance.
Re claims 2, 8, and 14, claim 1 of patent ‘895 is silent regarding the controller further configured to: prior to detection of the second operation, detect activation of a measurement mode; and detect completion of the measurement mode while the tip of the percutaneous intervention device is aligned with the second end of the structure, wherein the distance moved by the tip of the percutaneous intervention device from alignment with the first end of the structure to alignment with the second end of the structure is determined in response to detection of the completion of the measurement mode, and wherein determination of the distance comprises determination of the distance moved by the tip of the percutaneous intervention device from alignment with the first end of the structure to alignment with the second end of the structure while the measurement mode was active.
However, Lampropoulos teaches placing a tube member into a vein, using activation buttons to display a desired measurement, and the displaying the distance traveled as the tube member is moved (see at least para. 44). Therefore, the total distance traveled would be the distance measured from activation until tube movement has ended, equivalent to completion of the measurement mode.
It would have been obvious to one of ordinary skill in the art to modify patent ‘895 with the features of Lampropoulos because it allows for a user to specify when to start and stop measuring distance.
Re claims 3, 9, and 15, modified claim 1 of patent ‘895 teaches all the additional limitations.
Re claims 5, 11, and 17, claim 2 of patent ‘895 in view of modified claim 1 of patent ‘895 teaches all the additional limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT NGUYEN whose telephone number is (571)272-4838. The examiner can normally be reached M-F 8AM - 4PM ET.
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, ANNA MOMPER can be reached at (571) 270-5788. 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.
/ROBERT T NGUYEN/PRIMARY EXAMINER, Art Unit 3619
Prosecution Insights