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 - 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 16 of U.S. Patent No. 11,931,179. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to shape-sensing systems involving a medical device connector module, comprising:
a housing including a receptacle configured to receive a first plug to establish an optical connection between a medical device and the medical device connector module (reference claim 1, 8), the housing including a plurality of sensors configured to provide sensor data for determining a reference plane for shape sensing, the plurality of sensors including a gyroscope and an accelerometer (reference claim 4, 11, 16);
a cable extending from the housing, the cable including a second plug (reference claim 1, 8); and
an optical fiber extending from the receptacle through the cable to the second plug, the optical fiber configured to convey input optical signals from the optical interrogator to the receptacle and reflected optical signals from the receptacle to the optical interrogator (reference claim 2, 9).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include combine the limitations of reference claim 4, 11, and/or 16 with those of reference claim 2 and/or 9, because the optical fiber of reference claim 2/9 would be required in the invention of reference claim 4/11/16 in order to actually be able to use the sensor data as intended for determining a reference plane for the shape sensing, as recited in reference claim 4/11/16.
Specifically:
Instant claims 1, 10 are suggested by reference claim 2/9 and 4/11, as discussed above.
Instant claim 2 is suggested by reference claim 1/8. It is understood that the cables convey power/data.
Instant claims 3 - 8 are suggested by reference claim 6/7 and/or 13/14. The system of the reference claims is at least physically capable of being positioned as recited.
Instant claims 9 and 13 are suggested by reference claim 4/11/16.
Instant claims 11 - 12 are suggested by reference claim 8.
Instant claim 14 is suggested by reference claim 9/11. The system of the reference claims is at least physically capable of being used with a catheter.
Claims 1 - 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 16 of U.S. Patent No. 12,029,498. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to shape-sensing systems involving a medical device connector module.
Instant claims 1 - 4 are suggested by reference claims 1 - 4, respectively.
Instant claims 5 and 7 are suggested by reference claim 1.
Instant claim 6 is suggested by reference claim 5.
Instant claim 8 is suggested by reference claim 6.
Instant claims 9 and 13 are suggested by reference claims 1, 7, and /or 11.
Instant claims 10 - 12 are suggested by reference claims 7 - 9, respectively.
Instant claim 14 is suggested by reference 3, 10.
Claims 1 - 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 16 of U.S. Patent No. 12,564,453. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to shape-sensing systems involving a medical device connector module.
Instant claims 1 - 12 are suggested by reference claims 1 - 12, respectively.
Instant claim 13 is suggested by reference claim 9 and/or 13.
Instant claim 14 is suggested by reference claim 3 and/or 13.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 3 - 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hayes et al. (US 2017/0181646, of record) in view of Davis et al. (US 2015/0124266) and Cappadona et al. (US 2019/0183589).
Regarding claim 1, Hayes shows medical device connector module (“connector 16 which connects the distal fiber optic wire 30 and proximal fiber optic wire 32”, [0032] and figs. 1 - 2), comprising:
a housing (female housing 86, [0054] and fig. 2) including a receptacle (lumen 88, [0054] and fig. 2) configured to receive a first plug (male housing 80, [0054] and fig. 2) to establish an optical connection between a medical device (guidewire assembly 12, [0054] and figs. 1 - 2). and the medical device connector module (“… male housing 80 is engaged to the female housing 86, light is capable of being transmitted along the entire combined length of the optic fiber wires 30 and 32”, [0054])
a cable extending from the housing (proximal fiber optic wire 32, [0054] and fig. 2. Note: the optical fiber is interpreted as extending within a “cable” because it is understood that the optical fiber is not bare and unshielded1, but necessarily has some sort of insulation or cladding that allows it to be used to transmit signals to and from the remaining components of proximal assembly 14), the cable including a second plug (i.e., there is necessarily some physical component (i.e., a “plug”) present to exchange the signals between the optical fiber 32 and the remaining components of proximal assembly 14: 40, 60, 56, and “…components for sending and analyzing light signal(s) transmitted through the fiber optic wires 30 and 32”, [0031] and fig. 2); and
an optical fiber extending from the receptacle through the cable to the second plug, the optical fiber configured to convey input optical signals from the optical interrogator to the receptacle and reflected optical signals from the receptacle to the optical interrogator (“fiber 32 exists to carry the light through the circulator 52 and into the connector 16 … light is reflected from the FBGs 74, 75, the light passes back through the connector 16 and re-enters the proximal optic wire 32”, [0056]).
Hayes fails to show that the housing includes a plurality of sensors configured to provide sensor data for determining a reference plane for shape sensing, the plurality of sensors including a gyroscope and an accelerometer.
Davis discloses optical shape sensing systems. Davis teaches a housing includes a plurality of sensors configured to provide sensor data for determining a reference plane for shape sensing (“launch unit is coupled … optical fiber sensors… defines a coordinate frame for the optical shape sensing system measurements… inertial measurement unit (IMU)”, [0011]; [0054] - [0058]). However, Davis doesn’t explicitly state that the sensors comprise a gyroscope and an accelerometer.
Cappadona discloses tracking medical instruments. Cappadona teaches the sensors comprise a gyroscope and an accelerometer (“IMU is composed of a (i) gyroscope, (ii) accelerometer, and (iii) magnetometer”, [0069]; [0073]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hayes to have the housing include a plurality of sensors configured to provide sensor data for determining a reference plane for shape sensing, as taught by Davis, in order to defines a coordinate frame for the optical shape sensing system, as suggested by Davis ([0011]), to thereby facilitate accurate data analysis.
It also would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of
Hayes and Davis to have the sensors comprise a gyroscope and an accelerometer, as taught by Cappadona, in order to use the most common sensors to measure pose, as suggested by Cappadona ([0030]), thereby simplifying manufacturing and reducing expense.
Regarding claim 3, the combined invention of Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above. Further, the connector module of Hayes is capable of being positioned to sit within a fenestration of a surgical drape adjacent a percutaneous insertion site for a catheter, and therefore meets the claim.
Regarding claim 4, the combined invention of Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above. Further, it is at least physically possible to perform high-level disinfection or sterilization of the connector module of Hayes. The connector module is therefore interpreted as being “amenable to high-level disinfection or sterilization.”
Regarding claim 5, the combined invention of Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above. Further, it is at least physically possible to position the connector module of Hayes on a patient's chest beneath a surgical drape. The connector module of Hayes therefore meets the claim.
Regarding claim 6, the combined invention of Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above. Further, any point on the exterior surface of Hayes’ connector module is physically capable of being used as a “tether point” that can be used to attach a neck strap to the optical-fiber connector module, thereby enabling the optical-fiber connector module to be secured to the patient's neck while sitting on the patient's chest. The connector module of Hayes therefore meets the claim.
Regarding claim 7, the combined invention of Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above. The exterior surface of Hayes’ connector module has multiple surfaces (i.e., the front, back, top or bottom, as depicted in fig. 2, or any subset thereof) that are capable of being positioned to face the patient, and are thus interpreted as being “a patient-facing surface”. Any of these surfaces are at least physically capable of being adhered to the patient's chest, thereby enabling the connector module to be secured to the patient's chest while sitting on the patient's chest. The connector module of Hayes therefore meets the claim.
Regarding claim 8, combined invention of Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above. Hayes further shows that the receptacle includes an optical receiver configured to accept insertion of an optical terminal of the first plug and form an optical connection when the first plug is inserted into the receptacle, as the device is used to transmit signals to and from the remaining components of proximal assembly 14 (40, 60, 56, and “…components for sending and analyzing light signal(s) transmitted through the fiber optic wires 30 and 32”, [0031] and fig. 2). There is thus necessarily an “optical receiver” to receive the connection. Such connection is at least physically capable of being made “with the surgical drape therebetween, thereby enabling at least the optical connection from a sterile field to a non-sterile field”. The prior art therefore meets the claim.
Regarding claim 9, combined invention of Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above.
Hayes fails to show that the plurality of sensors further comprise a magnetometer.
Cappadona teaches that the plurality of sensors further comprise a magnetometer (“IMU is composed of a (i) gyroscope, (ii) accelerometer, and (iii) magnetometer”, [0069]; [0073]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Hayes and Davis to have the plurality of sensors further comprise a magnetometer, as taught by Cappadona, in order to use the most common sensors to measure pose, as suggested by Cappadona ([0030]), thereby simplifying manufacturing and reducing expense.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hayes, Davis, and Cappadona as applied to claim 1 above, and further in view of Whitmore et al. (US 2013/0245640, of record).
Regarding claim 2, the combined invention of Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above.
Hayes is silent as to power and data wires extending from the one or more sensors through the cable to the second plug or a third plug, the power and data wires configured to respectively convey power to the one or more sensors and data from the one or more sensors.
Whitmore discloses medical instrument navigation. Whitmore teaches power and data wires extending from a sensor through a cable to a plug, the power and data wires configured to respectively convey power to the sensor and data from the sensor (cable 25 that provides power from a power supply 27 and also serves as a data cable, [0029]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Hayes, Davis, and Cappadona to include power and data wires extending from the one or more sensors through the cable to the second plug or a third plug, the power and data wires configured to respectively convey power to the one or more sensors and data from the one or more sensors., as taught by Whitmore, in order to convey power and data, as is notoriously well-understood in the art.
Claims 10 - 11 and 13 - 14 are rejected under 35 U.S.C. 103 as being unpatentable over Duindam et al. (US 2017/0014194, of record) in view of Hayes et al. (US 2017/0181646, of record), Davis et al. (US 2015/0124266), and Cappadona et al. (US 2019/0183589).
Regarding claim 10, Duindam shows a shape-sensing system, comprising:
a stylet including an optical fiber (“shape sensor … stylet,” [0015]; “shape sensor 120 … part of a flexible stylet …,” [0038] and fig. 3D) having a plurality of fiber Bragg grating ("FBG") sensors (FBGs, [0047]) along a length of the stylet;
a console including memory and a processor (“processor 140 for processing the measurement data from a fiber optic shape sensor 120,” [0051] - [0052] and fig. 1B) for converting reflected optical signals from the optical-fiber stylet into shapes for the medical device for display (“… necessary graphical representation of the measurements of shape sensor 120… visual representation of the shape data measured by shape sensor 120,” [0054]).
Duindam is silent as to the mechanism by which the optical-fiber is connected to the console. In particular, Duindam fails to show:
medical device connector module, comprising:
a housing including a receptacle configured to receive a first plug to establish an optical connection between a medical device and the medical device connector module, the housing including a plurality of sensors configured to provide sensor data for determining a reference plane for shape sensing, the plurality of sensors including a gyroscope and an accelerometer;
a cable extending from the housing, the cable including a second plug; and
an optical fiber extending from the receptacle through the cable to the second plug, the optical fiber configured to convey input optical signals from the optical interrogator to the receptacle and reflected optical signals from the receptacle to the optical interrogator.
Hayes discloses medical instruments including FBG shape sensors. Hayes shows a medical device connector module (“connector 16 which connects the distal fiber optic wire 30 and proximal fiber optic wire 32”, [0032] and figs. 1 - 2), comprising:
a housing (female housing 86, [0054] and fig. 2) including a receptacle (lumen 88, [0054] and fig. 2) configured to receive a first plug (male housing 80, [0054] and fig. 2) to establish an optical connection between a medical device (guidewire assembly 12, [0054] and figs. 1 - 2). and the medical device connector module (“… male housing 80 is engaged to the female housing 86, light is capable of being transmitted along the entire combined length of the optic fiber wires 30 and 32”, [0054])
a cable extending from the housing (proximal fiber optic wire 32, [0054] and fig. 2. Note: the optical fiber is interpreted as extending within a “cable” because it is understood that the optical fiber is not bare and unshielded2, but necessarily has some sort of insulation or cladding that allows it to be used to transmit signals to and from the remaining components of proximal assembly 14), the cable including a second plug (i.e., there is necessarily some physical component (i.e., a “plug”) present to exchange the signals between the optical fiber 32 and the remaining components of proximal assembly 14: 40, 60, 56, and “…components for sending and analyzing light signal(s) transmitted through the fiber optic wires 30 and 32”, [0031] and fig. 2); and
an optical fiber extending from the receptacle through the cable to the second plug, the optical fiber configured to convey input optical signals from the optical interrogator to the receptacle and reflected optical signals from the receptacle to the optical interrogator (“fiber 32 exists to carry the light through the circulator 52 and into the connector 16 … light is reflected from the FBGs 74, 75, the light passes back through the connector 16 and re-enters the proximal optic wire 32”, [0056]).
Davis discloses optical shape sensing systems. Davis teaches a housing includes a plurality of sensors configured to provide sensor data for determining a reference plane for shape sensing (“launch unit is coupled … optical fiber sensors… defines a coordinate frame for the optical shape sensing system measurements… inertial measurement unit (IMU)”, [0011]; [0054] - [0058]). However, Davis doesn’t explicitly state that the sensors comprise a gyroscope and an accelerometer.
Cappadona discloses tracking medical instruments. Cappadona teaches the sensors comprise a gyroscope and an accelerometer (“IMU is composed of a (i) gyroscope, (ii) accelerometer, and (iii) magnetometer”, [0069]; [0073]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Duindam to include a medical device connector module, as taught by Hayes, in order to facilitate removable coupling of the instrument to the console, to allow for greater ease of use, as suggested by Hayes ([0053]).
It also would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Duindam and Hayes to have the housing include a plurality of sensors configured to provide sensor data for determining a reference plane for shape sensing, as taught by Davis, in order to defines a coordinate frame for the optical shape sensing system, as suggested by Davis ([0011]), to thereby facilitate accurate data analysis.
It would further have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of
Duindam, Hayes, and Davis to have the sensors comprise a gyroscope and an accelerometer, as taught by Cappadona, in order to use the most common sensors to measure pose, as suggested by Cappadona ([0030]), thereby simplifying manufacturing and reducing expense.
In the combined invention of the prior art, the stylet would include the first plug, as the stylet is the medical device that is connected to the connector module. Alternatively, such modification would be obvious in order to use the stylet and connector module together.
Regarding claim 11, the combined invention of Duindam, Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above. Duindam further shows that the console includes the optical interrogator (interrogator 141, [0052]).
Regarding claim 13, the combined invention of Duindam, Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above.
Duindam fails to show that the plurality of sensors further comprise a magnetometer.
Cappadona teaches that the plurality of sensors further comprise a magnetometer (“IMU is composed of a (i) gyroscope, (ii) accelerometer, and (iii) magnetometer”, [0069]; [0073]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Duindam, Hayes, and Davis to have the plurality of sensors further comprise a magnetometer, as taught by Cappadona, in order to use the most common sensors to measure pose, as suggested by Cappadona ([0030]), thereby simplifying manufacturing and reducing expense.
Regarding claim 14, the combined invention of Duindam, Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above. Duindam further shows the medical device is a catheter, and wherein the stylet is configured for insertion into a lumen of the catheter ([0038]). Alternatively, the combined invention of the prior art is at least physically capable of being used with a medical device comprising a catheter.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Duindam, Hayes, Davis, and Cappadona, as applied to claim 10 above, and further in view of Flexman et al. (US 2016/0213432, of record).
Regarding claim 12, the combined invention of Duindam, Hayes, Davis, and Cappadona discloses the claimed invention substantially as noted above.
Duindam fails to show that the optical interrogator is a stand-alone unit communicatively coupled to the console.
Flexman discloses shape sensing optical fiber registration tools and methods ([0002]). Flexman teaches an optical interrogator that is a stand-alone unit communicatively coupled to a console (“optical fibers connect to the workstation 112 through interrogation modules 117a and 117b, which may be part of the console 112 or may be independent module,” [0045] and fig. 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention Duindam, Hayes, Davis, and Cappadona o have the optical interrogator be a stand-alone unit communicatively coupled to the console, as taught by Flexman, in order to provide a modular arrangement that facilitates ease of repair or replacement of interrogator components. Such modification would have amounted to no more than making known components separable, which has previously been held to be prima facie obvious. See MPEP 2144.04.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
1 Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the optical fiber to be within a cable, in order to protect the fiber from mechanical damage and ambient light, as is conventional in the art.
2 Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the optical fiber to be within a cable, in order to protect the fiber from mechanical damage and ambient light, as is conventional in the art.
