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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of U.S. Patent No. 10,943,775 in further view of Wiseman et al. U.S. PGPUB No. 2012/0080592. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 24 (and claim 1 upon which it depends) anticipates every limitation of claim 1 of the immediate application except that there is no disclosure that the reservoir is configured to form and hold a droplet of the solvent in direct contact with a tissue site.
Wiseman discloses a probe comprising: a reservoir, a first conduit, a second conduit, and a third conduit (as illustrated in the annotated copy of figure 2, below)
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wherein: the reservoir* is in fluid communication with the first conduit 1, the second conduit 11 and the third conduit 3; the first conduit 1 is configured to provide fluid communication between a chamber comprising a solvent (“irrigation fluid 2 which may be fed to the irrigation capillary 1 through the irrigation port 6 and the irrigation connector 5” [0040] – “a conduit for irrigating the site of analysis with a solvent, carrier or other fluid” [0029]) and the reservoir* (as illustrated in figure 2); the second conduit 11 is configured to provide fluid communication between a gas supply and the reservoir (“Carrier gas 12 enters the carrier gas capillary 11 through a carrier gas port 13 and carrier gas connector 14, providing a gas flow through the carrier gas capillary 11 to enhance transport of the analytes desorbed from the target into and through the probe pick-up” [0043]); the third conduit 3 is configured to provide fluid communication between the reservoir and a mass spectrometer (“Member 3 includes a capillary comprising a metal such as titanium, stainless steel or tungsten, or a suitable composite or polymeric material, such as a piezoceramic in an epoxy matrix, or a piezoelectric plastic such as polyvinylidenefluoride (PVDF)” [0040] – “Desorbed analytes enter the irrigation fluid 2 and the aspirator 9 produces dynamic draw to aspirate the desorbed analytes into the sampling tip 4 through the capillary and into the connecting body, 8, for delivery of the analyte/effluent 10 to an analysis instrument” [0040] – “the analyzer may be an ion mass spectrometer, a quadrupole mass spectrometer, a triple quadrupole tandem mass spectrometer, an ion mobility analyzer or other ion analysis instrument” [0044]); the reservoir is configured to form and hold a droplet of the solvent (“In operation, the ultrasonic energy may disperse the desorbed material and irrigant into small droplets” [0042]) in direct contact (“The solvent is in contact with the sample and forms a stable liquid junction” [0008]) with a tissue site (“…in vivo analysis of tissue for the determination of tumor margins or detection of particular markers of disease or for any type of surgical application to optimize the definition of surgical boundaries” [0015]). Wiseman does not explicitly identify a reservoir per se, but such a reservoir is necessarily formed by the droplets of irrigant and solvent, provided with carrier gas, at the interface between the sampling tip and tissue surface, as illustrated in the annotated copy of figure 2, above.
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 24 of U.S. Patent No. 10,943,775 with the droplet of solvent, disclosed in Wiseman, in order to ensure that a desired amount of sample is ablated for analysis, such that the amount of ablation is enough for accurate detection, but not so much as to be harmful to a living sample.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of U.S. Patent No. 10,943,775 in further view of Venter et al. U.S. PGPUB No. 2008/0156985. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 24 (and claim 1 upon which it depends) anticipates every limitation of claim 1 of the immediate application except that there is no disclosure that the reservoir is configured to form and hold a droplet of the solvent in direct contact with a tissue site.
Venter discloses a probe comprising: a reservoir (“ENCLOSURE”), a first conduit of the “DESI SPRAYER”, a second conduit of the “DESI SPRAYER”, and a third conduit (“MS INLET CAPILLARY”) wherein: the reservoir (“ENCLOSURE”) is in fluid communication with the first conduit of the “DESI SPRAYER”, the second conduit of the “DESI SPRAYER” and the third conduit (“MS INLET CAPILLARY”), as illustrated in, for example, figure 1D; the first conduit of the “DESI SPRAYER” is configured to provide fluid communication between a chamber comprising a solvent and the reservoir (“the internal solvent capillary was a section of fused silica capillary tubing with an inner diameter of 50 µm and an outer diameter of 190 µm. The capillary extended through the T-piece and was connected to a syringe pump” [0037]); the second conduit of the “DESI SPRAYER” is configured to provide fluid communication between a gas supply and the reservoir (“This was connected through the T-piece to a nitrogen tank supply which was operated at 1380 kPa (200 psi, 35 L/min). The inner solvent capillary extended ca. 0.3 mm beyond the outer gas capillary” [0037]); the third conduit (“MS INLET CAPILLARY”) is configured to provide fluid communication between the reservoir and a mass spectrometer (“the process of creating ions directly from sample surfaces for mass spectrometric (MS) analysis by impinging a liquid spray onto the surface” [Abstract]); the reservoir (“ENCLOSURE”) is configured to form and hold a droplet of the solvent in direct contact with a tissue site (“The new-source enhances transport of ions produced during or after droplet--surface interaction” [0007] – the use of the word “during” implies a duration of time when the droplet is present on the surface of the tissue site).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 24 of U.S. Patent No. 10,943,775 with the droplet of solvent, disclosed in Venter, in order to ensure that a desired amount of sample is ablated for analysis, such that the amount of ablation is enough for accurate detection, but not so much as to be harmful to a living sample.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of U.S. Patent No. 10,943,775 in further view of Jarrell et al. U.S. PGPUB No. 2010/0148057. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 24 (and claim 1 upon which it depends) anticipates every limitation of claim 1 of the immediate application except that there is no disclosure that the reservoir is configured to form and hold a droplet of the solvent in direct contact with a tissue site.
Jarrell discloses a probe comprising: a reservoir 102, a first conduit 134, a second conduit 104, and a third conduit 118 wherein: the reservoir 102 is in fluid communication with the first conduit 134, the second conduit 104 and the third conduit 118; the first conduit 134 is configured to provide fluid communication between a chamber 138 comprising a solvent (“solvent source 138” [0076]) and the reservoir 102; the second conduit 104 is configured to provide fluid communication between a gas supply 106 and the reservoir 102; the third conduit 118 is configured to provide fluid communication between the reservoir 102 and a mass spectrometer 108 (“detector 108 is a mass spectrometer” [0081]); the reservoir 102 is configured to form and hold a droplet of the solvent in direct contact with a tissue site (“The electrospray needle is for directing charged solvent droplets toward said sampling region, such that at least a further portion of the desorbed sample is ionized to produce further sample ions” [0015]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 24 of U.S. Patent No. 10,943,775 with the droplet of solvent, disclosed in Venter, in order to ensure that a desired amount of sample is ablated for analysis, such that the amount of ablation is enough for accurate detection, but not so much as to be harmful to a living sample.
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.
Claim(s) 1, 2, 3, 4, 7, 8, 9, 10, 13, 14, 15, 16, 17, 18, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiseman et al. U.S. PGPUB No. 2012/0080592 in view of Agar U.S. PGPUB No. 2016/0341712.
Regarding claim 1, Wiseman discloses a probe comprising: a reservoir, a first conduit, a second conduit, and a third conduit (as illustrated in the annotated copy of figure 2, below)
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wherein: the reservoir* is in fluid communication with the first conduit 1, the second conduit 11 and the third conduit 3; the first conduit 1 is configured to provide fluid communication between a chamber comprising a solvent (“irrigation fluid 2 which may be fed to the irrigation capillary 1 through the irrigation port 6 and the irrigation connector 5” [0040] – “a conduit for irrigating the site of analysis with a solvent, carrier or other fluid” [0029]) and the reservoir* (as illustrated in figure 2); the second conduit 11 is configured to provide fluid communication between a gas supply and the reservoir (“Carrier gas 12 enters the carrier gas capillary 11 through a carrier gas port 13 and carrier gas connector 14, providing a gas flow through the carrier gas capillary 11 to enhance transport of the analytes desorbed from the target into and through the probe pick-up” [0043]); the third conduit 3 is configured to provide fluid communication between the reservoir and a mass spectrometer (“Member 3 includes a capillary comprising a metal such as titanium, stainless steel or tungsten, or a suitable composite or polymeric material, such as a piezoceramic in an epoxy matrix, or a piezoelectric plastic such as polyvinylidenefluoride (PVDF)” [0040] – “Desorbed analytes enter the irrigation fluid 2 and the aspirator 9 produces dynamic draw to aspirate the desorbed analytes into the sampling tip 4 through the capillary and into the connecting body, 8, for delivery of the analyte/effluent 10 to an analysis instrument” [0040] – “the analyzer may be an ion mass spectrometer, a quadrupole mass spectrometer, a triple quadrupole tandem mass spectrometer, an ion mobility analyzer or other ion analysis instrument” [0044]); the reservoir is configured to form and hold a droplet of the solvent (“In operation, the ultrasonic energy may disperse the desorbed material and irrigant into small droplets” [0042]) in direct contact (“The solvent is in contact with the sample and forms a stable liquid junction” [0008]) with a tissue site (“…in vivo analysis of tissue for the determination of tumor margins or detection of particular markers of disease or for any type of surgical application to optimize the definition of surgical boundaries” [0015]).
Wiseman does not explicitly identify a reservoir per se, but such a reservoir is necessarily formed by the droplets of irrigant and solvent, provided with carrier gas, at the interface between the sampling tip and tissue surface, as illustrated in the annotated copy of figure 2, above.
Wiseman discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Wiseman with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 2, Wiseman discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]). Agar discloses that the tracking device is configured to communicate the location of the tissue site (“The stereotactic tracking elements may then be used to track the probe 106 or the location from which a tissue sample was manually resected within the anatomical image” [0089]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Wiseman with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 3, Wiseman discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]). Agar discloses that the tracking device is configured to communicate with an imaging device to thereby map the location of the probe onto images collected with the imaging device (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Wiseman with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 4, Wiseman discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]). Agar discloses that the tracking device is further configured to communicate with the mass spectrometer to thereby correlate the location of the probe with mass spectroscopy data collected with the mass spectrometer (“Fluidly integrating all of this information, in a rapid timeframe, should significantly enhance a surgeon's capacity to achieve optimal tumor resection and would provide the foundation for surgery guided by metabolite-imaging mass spectrometry” [0171]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Wiseman with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 7, Wiseman discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe wherein the tracking device is part of a RF surgical tracking system (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure. The imaging procedure can include, among other things, a magnetic resonance imaging procedure, an ultrasound imaging procedure, and the like” [0101]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Wiseman with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 8, Wiseman discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe wherein the tracking device is part of a RF surgical tracking system (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure. The imaging procedure can include, among other things, a magnetic resonance imaging procedure, an ultrasound imaging procedure, and the like” [0101]). Agar discloses that the tracking device is part of an intra-operative ultrasound imaging system (“The first implementation of mass spectrometry within an operating room for the molecular characterization of tissue as part of an image-guided therapy program is also presented. The findings were cross-validated using standard pathology techniques. Measuring specific metabolites in tumor tissues with precise spatial distribution and under ambient conditions provides a new paradigm for intraoperative surgical decision-making, rapid diagnosis, and patient care management” [0187]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Wiseman with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 9, Wiseman discloses that the probe is comprised in a housing that is designed to be hand-held (“The probe may be substantially hand-held to enable the user to select sites for sampling on ordinary objects in the open atmosphere, or may be a machine-manipulable probe adapted for automated surface sampling” [0028]).
Regarding claim 10, Wiseman discloses that the probe is comprised in a housing that is designed to be coupled to laparoscopic surgical device (“A system and sampling probe adaptable to an ultrasonic surgical instrument applies irrigation fluid and ultrasonic or vibrational energy to a target, and aspirates material desorbed from the target into a pick-up conduit” [Abstract]).
Regarding claim 13, Wiseman discloses that the third conduit 3 is not directly coupled to the mass spectrometer, but is first coupled to ultrasonic transducer 7, output connector 8, aspirator 9, and ionization region 10 (as illustrated in figure 2).
Regarding claim 14, Wiseman discloses a method for assessing tissue, the method comprising: applying a droplet of the solvent to the tissue site (“the ultrasonic energy may disperse the desorbed material and irrigant into small droplets… smaller semi-volatile and volatile molecules will evaporate off with the solvent. When such molecules are ions within the droplets, they can be detected when passed to a mass spectrometer” [0042]) using the probe of claim 1 (as described above, with respect to the rejection of claim 1); collecting the applied solvent with the probe to obtain a liquid sample from the tissue site (“Desorbed analytes enter the irrigation fluid 2 and the aspirator 9 produces dynamic draw to aspirate the desorbed analytes into the sampling tip 4 through the capillary and into the connecting body, 8, for delivery of the analyte/effluent 10 to an analysis instrument” [0040]); transferring the liquid sample to a mass spectrometer via the third conduit (“Desorbed analytes enter the irrigation fluid 2 and the aspirator 9 produces dynamic draw to aspirate the desorbed analytes into the sampling tip 4 through the capillary and into the connecting body, 8, for delivery of the analyte/effluent 10 to an analysis instrument” [0040] – “the analyzer may be an ion mass spectrometer” [0044]); and subjecting the liquid sample to mass spectrometry analysis to thereby obtain a mass spectrometry profile corresponding to the tissue site (“a spectrometer to detect absorbance or emission spectra” [0012]).
Regarding claim 15, Wiseman discloses that the liquid sample is obtained in vivo (“the probe applies sufficient energy to disrupt live tissue for the analysis of cellular contents and/or extracellular matrix material in vitro or in vivo, for example, to detect specific material or to determine tumor margins in real time” [0028]).
Regarding claim 16, Wiseman discloses that the liquid sample is obtained ex vivo (“the probe applies sufficient energy to disrupt live tissue for the analysis of cellular contents and/or extracellular matrix material in vitro or in vivo, for example, to detect specific material or to determine tumor margins in real time” [0028]).
Regarding claim 17, Wiseman discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]). Agar discloses that when an operator initiates collection of the liquid sample, then a tracking system records location of the probe in an associated imaging system that is in communication with the tracking device (“Regardless of whether additional imaging or tracking systems are used, the system 100 provides the surgeon with real-time and direct feedback about the operating site” [0017]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Wiseman with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 18, Wiseman discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe such that mapping the location of the probe is mapped onto images collected with the imaging system (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101] – “Regardless of whether additional imaging or tracking systems are used, the system 100 provides the surgeon with real-time and direct feedback about the operating site” [0017]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Wiseman with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 19, Wiseman discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe and correlating the location of the probe and/or the images with the mass spectrometry profile (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101] – “the surgeon may track the location within an additional image of where the tissue sample was collected and correlate the report details, such as the spectroscopy images, to the exact location” [0089]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Wiseman with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 20, Wiseman discloses characterizing the liquid sample based on the mass spectrometry profile (“Analytes sampled by the present invention are presented in an aspirated stream for analysis by a mass spectrometer or other instrumentation capable of analyzing atoms, molecules, molecular clusters or intact cells” [0029] – “the in vivo analysis of tissue for the determination of tumor margins or detection of particular markers of disease or for any type of surgical application to optimize the definition of surgical boundaries, or for the detection and quantification of drug uptake” [0015]).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiseman et al. U.S. PGPUB No. 2012/0080592 in view of Agar U.S. PGPUB No. 2016/0341712 in further view of Presthus et al. U.S. PGPUB No. 2006/0205996.
Regarding claim 5, Wiseman and Agar disclose the claimed invention except that while Agar discloses a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]), Wiseman and Agar do not explicitly disclose that the tracking device is an RF emitter.
Presthus discloses monitoring the position of a medical probe using RF energy waves (“an RF coupling can be used to transmit and receive RF energy waves 151 to monitor the position of the probe relative to the urethral guide” [0093]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe tracking of Wiseman and Agar with the RF probe tracking of Presthus in order to utilize known probe tracking mechanisms, so as to select a probe tracking mechanism which is most useful to a specific application – for instance, relying on RF tracking when visual tracking of a probe may be obscured or otherwise not preferable.
Regarding claim 6, Wiseman and Agar disclose the claimed invention except that while Agar discloses a tracking device is configured to track a location of the surgical probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101] – “Fluidly integrating all of this information, in a rapid timeframe, should significantly enhance a surgeon's capacity to achieve optimal tumor resection and would provide the foundation for surgery guided by metabolite-imaging mass spectrometry” [0171]), Wiseman and Agar do not explicitly disclose that the tracking device is an RF emitter.
Presthus discloses monitoring the position of a medical probe using RF energy waves (“an RF coupling can be used to transmit and receive RF energy waves 151 to monitor the position of the probe relative to the urethral guide” [0093]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe tracking of Wiseman and Agar with the RF probe tracking of Presthus in order to utilize known probe tracking mechanisms, so as to select a probe tracking mechanism which is most useful to a specific application – for instance, relying on RF tracking when visual tracking of a probe may be obscured or otherwise not preferable.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiseman et al. U.S. PGPUB No. 2012/0080592 in view of Agar U.S. PGPUB No. 2016/0341712 in further view of Karancsi et al. U.S. PGPUB No. 2018/0238776.
Regarding claim 11, Wiseman discloses the claimed invention except that there is no explicit disclosure that the surgical probe (“an ultrasonic surgical instrument applies irrigation fluid and ultrasonic or vibrational energy to a target” [Abstract]) is disposable.
Karancsi discloses a surgical [0003] probe for ablating [0323] a tissue [0003] sample for analysis in a mass spectrometer (“Rapid evaporative ionisation mass spectrometry (“REIMS”) may be used for the real time identification of tissues, e.g., during surgical interventions. Coupling of mass spectrometry with a surgical diathermy device has resulted in a sampling technology which has an intra-operative tissue identification accuracy of 92-100%” [0003]), wherein the surgical probe is disposable (“the apparatus may be arranged to have a minimal dead volume thus ensuring fast operation and minimal delay time, to avoid significant memory effects, to have a sufficient trapping volume in order to store the liquid aspirated, e.g., during a surgical intervention, to be easily cleanable and/or to be disposable” [0020]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Wiseman and Agar with the disposable probe of Karancsi in order to aid in cleanliness of surfaces utilized in a surgical procedure performed with a hand-held sampling probe.
Regarding claim 12, Wiseman discloses the claimed invention except that there is no explicit disclosure that the surgical probe (“an ultrasonic surgical instrument applies irrigation fluid and ultrasonic or vibrational energy to a target” [Abstract]) comprises a collection tip that is ejectable.
Karancsi discloses a surgical [0003] probe for ablating [0323] a tissue [0003] sample for analysis in a mass spectrometer (“Rapid evaporative ionisation mass spectrometry (“REIMS”) may be used for the real time identification of tissues, e.g., during surgical interventions. Coupling of mass spectrometry with a surgical diathermy device has resulted in a sampling technology which has an intra-operative tissue identification accuracy of 92-100%” [0003]), wherein the surgical probe is ejectable (“the apparatus may be arranged to have a minimal dead volume thus ensuring fast operation and minimal delay time, to avoid significant memory effects, to have a sufficient trapping volume in order to store the liquid aspirated, e.g., during a surgical intervention, to be easily cleanable and/or to be disposable” [0020]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Wiseman and Agar with the disposable probe of Karancsi in order to aid in cleanliness of surfaces utilized in a surgical procedure performed with a hand-held sampling probe. Further, it has been held that making two items separable requires only routine skill in the art, In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961), see MPEP 2144.04 V.C.
Claim(s) 1, 2, 3, 4, 7, 8, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jarrell et al. U.S. PGPUB No. 2010/0148057 in view of Agar U.S. PGPUB No. 2016/0341712.
Regarding claim 1, Jarrell discloses a probe comprising: a reservoir 102, a first conduit 134, a second conduit 104, and a third conduit 118 wherein: the reservoir 102 is in fluid communication with the first conduit 134, the second conduit 104 and the third conduit 118; the first conduit 134 is configured to provide fluid communication between a chamber 138 comprising a solvent (“solvent source 138” [0076]) and the reservoir 102; the second conduit 104 is configured to provide fluid communication between a gas supply 106 and the reservoir 102; the third conduit 118 is configured to provide fluid communication between the reservoir 102 and a mass spectrometer 108 (“detector 108 is a mass spectrometer” [0081]); the reservoir 102 is configured to form and hold a droplet of the solvent in direct contact with a tissue site (“The electrospray needle is for directing charged solvent droplets toward said sampling region, such that at least a further portion of the desorbed sample is ionized to produce further sample ions” [0015]). Jarrell discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Jarrell with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 2, Jarrell discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]). Agar discloses that the tracking device is configured to communicate the location of the tissue site (“The stereotactic tracking elements may then be used to track the probe 106 or the location from which a tissue sample was manually resected within the anatomical image” [0089]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Jarrell with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 3, Jarrell discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]). Agar discloses that the tracking device is configured to communicate with an imaging device to thereby map the location of the probe onto images collected with the imaging device (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Jarrell with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 4, Jarrell discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]). Agar discloses that the tracking device is further configured to communicate with the mass spectrometer to thereby correlate the location of the probe with mass spectroscopy data collected with the mass spectrometer (“Fluidly integrating all of this information, in a rapid timeframe, should significantly enhance a surgeon's capacity to achieve optimal tumor resection and would provide the foundation for surgery guided by metabolite-imaging mass spectrometry” [0171]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Jarrell with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 7, Jarrell discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe wherein the tracking device is part of a RF surgical tracking system (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure. The imaging procedure can include, among other things, a magnetic resonance imaging procedure, an ultrasound imaging procedure, and the like” [0101]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Jarrell with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 8, Jarrell discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe wherein the tracking device is part of a RF surgical tracking system (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure. The imaging procedure can include, among other things, a magnetic resonance imaging procedure, an ultrasound imaging procedure, and the like” [0101]). Agar discloses that the tracking device is part of an intra-operative ultrasound imaging system (“The first implementation of mass spectrometry within an operating room for the molecular characterization of tissue as part of an image-guided therapy program is also presented. The findings were cross-validated using standard pathology techniques. Measuring specific metabolites in tumor tissues with precise spatial distribution and under ambient conditions provides a new paradigm for intraoperative surgical decision-making, rapid diagnosis, and patient care management” [0187]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Jarrell with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 13, Jarrell discloses that the third conduit 118 is not directly coupled to the mass spectrometer, but is first coupled to inlet 110 (as illustrated in figure 5).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jarrell et al. U.S. PGPUB No. 2010/0148057 in view of Agar U.S. PGPUB No. 2016/0341712 in further view of Presthus et al. U.S. PGPUB No. 2006/0205996.
Regarding claim 5, Jarrell and Agar disclose the claimed invention except that while Agar discloses a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]), Jarrell and Agar do not explicitly disclose that the tracking device is an RF emitter.
Presthus discloses monitoring the position of a medical probe using RF energy waves (“an RF coupling can be used to transmit and receive RF energy waves 151 to monitor the position of the probe relative to the urethral guide” [0093]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe tracking of Jarrell and Agar with the RF probe tracking of Presthus in order to utilize known probe tracking mechanisms, so as to select a probe tracking mechanism which is most useful to a specific application – for instance, relying on RF tracking when visual tracking of a probe may be obscured or otherwise not preferable.
Regarding claim 6, Jarrell and Agar disclose the claimed invention except that while Agar discloses a tracking device is configured to track a location of the surgical probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101] – “Fluidly integrating all of this information, in a rapid timeframe, should significantly enhance a surgeon's capacity to achieve optimal tumor resection and would provide the foundation for surgery guided by metabolite-imaging mass spectrometry” [0171]), Jarrell and Agar do not explicitly disclose that the tracking device is an RF emitter.
Presthus discloses monitoring the position of a medical probe using RF energy waves (“an RF coupling can be used to transmit and receive RF energy waves 151 to monitor the position of the probe relative to the urethral guide” [0093]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe tracking of Jarrell and Agar with the RF probe tracking of Presthus in order to utilize known probe tracking mechanisms, so as to select a probe tracking mechanism which is most useful to a specific application – for instance, relying on RF tracking when visual tracking of a probe may be obscured or otherwise not preferable.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jarrell et al. U.S. PGPUB No. 2010/0148057 in view of Agar U.S. PGPUB No. 2016/0341712 in further view of Karancsi et al. U.S. PGPUB No. 2018/0238776.
Regarding claim 11, Jarrell discloses the claimed invention except that there is no explicit disclosure that the probe is disposable.
Karancsi discloses a surgical [0003] probe for ablating [0323] a tissue [0003] sample for analysis in a mass spectrometer (“Rapid evaporative ionisation mass spectrometry (“REIMS”) may be used for the real time identification of tissues, e.g., during surgical interventions. Coupling of mass spectrometry with a surgical diathermy device has resulted in a sampling technology which has an intra-operative tissue identification accuracy of 92-100%” [0003]), wherein the surgical probe is disposable (“the apparatus may be arranged to have a minimal dead volume thus ensuring fast operation and minimal delay time, to avoid significant memory effects, to have a sufficient trapping volume in order to store the liquid aspirated, e.g., during a surgical intervention, to be easily cleanable and/or to be disposable” [0020]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Jarrell and Agar with the disposable probe of Karancsi in order to aid in cleanliness of surfaces utilized in a surgical procedure performed with a hand-held sampling probe.
Regarding claim 12, Jarrell discloses the claimed invention except that there is no explicit disclosure that the probe comprises a collection tip that is ejectable.
Karancsi discloses a surgical [0003] probe for ablating [0323] a tissue [0003] sample for analysis in a mass spectrometer (“Rapid evaporative ionisation mass spectrometry (“REIMS”) may be used for the real time identification of tissues, e.g., during surgical interventions. Coupling of mass spectrometry with a surgical diathermy device has resulted in a sampling technology which has an intra-operative tissue identification accuracy of 92-100%” [0003]), wherein the surgical probe is ejectable (“the apparatus may be arranged to have a minimal dead volume thus ensuring fast operation and minimal delay time, to avoid significant memory effects, to have a sufficient trapping volume in order to store the liquid aspirated, e.g., during a surgical intervention, to be easily cleanable and/or to be disposable” [0020]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Jarrell and Agar with the disposable probe of Karancsi in order to aid in cleanliness of surfaces utilized in a surgical procedure performed with a hand-held sampling probe. Further, it has been held that making two items separable requires only routine skill in the art, In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961), see MPEP 2144.04 V.C.
Claim(s) 1, 2, 3, 4, 7, 8, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Venter et al. U.S. PGPUB No. 2008/0156985 in view of Agar U.S. PGPUB No. 2016/0341712.
Regarding claim 1, Venter discloses a probe comprising: a reservoir (“ENCLOSURE”), a first conduit of the “DESI SPRAYER”, a second conduit of the “DESI SPRAYER”, and a third conduit (“MS INLET CAPILLARY”) wherein: the reservoir (“ENCLOSURE”) is in fluid communication with the first conduit of the “DESI SPRAYER”, the second conduit of the “DESI SPRAYER” and the third conduit (“MS INLET CAPILLARY”), as illustrated in, for example, figure 1D; the first conduit of the “DESI SPRAYER” is configured to provide fluid communication between a chamber comprising a solvent and the reservoir (“the internal solvent capillary was a section of fused silica capillary tubing with an inner diameter of 50 µm and an outer diameter of 190 µm. The capillary extended through the T-piece and was connected to a syringe pump” [0037]); the second conduit of the “DESI SPRAYER” is configured to provide fluid communication between a gas supply and the reservoir (“This was connected through the T-piece to a nitrogen tank supply which was operated at 1380 kPa (200 psi, 35 L/min). The inner solvent capillary extended ca. 0.3 mm beyond the outer gas capillary” [0037]); the third conduit (“MS INLET CAPILLARY”) is configured to provide fluid communication between the reservoir and a mass spectrometer (“the process of creating ions directly from sample surfaces for mass spectrometric (MS) analysis by impinging a liquid spray onto the surface” [Abstract]); the reservoir (“ENCLOSURE”) is configured to form and hold a droplet of the solvent in direct contact with a tissue site (“The new-source enhances transport of ions produced during or after droplet--surface interaction” [0007]). Venter discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Venter with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 2, Venter discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]). Agar discloses that the tracking device is configured to communicate the location of the tissue site (“The stereotactic tracking elements may then be used to track the probe 106 or the location from which a tissue sample was manually resected within the anatomical image” [0089]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Venter with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 3, Venter discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]). Agar discloses that the tracking device is configured to communicate with an imaging device to thereby map the location of the probe onto images collected with the imaging device (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Venter with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 4, Venter discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]). Agar discloses that the tracking device is further configured to communicate with the mass spectrometer to thereby correlate the location of the probe with mass spectroscopy data collected with the mass spectrometer (“Fluidly integrating all of this information, in a rapid timeframe, should significantly enhance a surgeon's capacity to achieve optimal tumor resection and would provide the foundation for surgery guided by metabolite-imaging mass spectrometry” [0171]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Venter with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 7, Venter discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe wherein the tracking device is part of a RF surgical tracking system (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure. The imaging procedure can include, among other things, a magnetic resonance imaging procedure, an ultrasound imaging procedure, and the like” [0101]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Venter with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 8, Venter discloses the claimed invention but does not explicitly disclose a tracking device is configured to track a location of the probe.
Agar discloses a hand-held probe for ablating a tissue [0082] sample (“A hand held sampling probe can be used that allows a surgeon to collect samples intra-operatively from target areas of a surgery site” [0012]) for analysis in a mass spectrometer [0082], wherein a tracking device is configured to track a location of the probe wherein the tracking device is part of a RF surgical tracking system (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure. The imaging procedure can include, among other things, a magnetic resonance imaging procedure, an ultrasound imaging procedure, and the like” [0101]). Agar discloses that the tracking device is part of an intra-operative ultrasound imaging system (“The first implementation of mass spectrometry within an operating room for the molecular characterization of tissue as part of an image-guided therapy program is also presented. The findings were cross-validated using standard pathology techniques. Measuring specific metabolites in tumor tissues with precise spatial distribution and under ambient conditions provides a new paradigm for intraoperative surgical decision-making, rapid diagnosis, and patient care management” [0187]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Venter with the probe tracking of Agar in order to more precisely ensure that a sampling probe is guided to a desired location, thereby analyzing only a desired portion and not other portions which are not desired for analysis.
Regarding claim 9, Venter discloses that the probe is comprised in a housing that is designed to be hand-held (“portable mass spectrometers, can use the sources of the present invention” [0050]).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Venter et al. U.S. PGPUB No. 2008/0156985 in view of Agar U.S. PGPUB No. 2016/0341712 in further view of Presthus et al. U.S. PGPUB No. 2006/0205996.
Regarding claim 5, Venter and Agar disclose the claimed invention except that while Agar discloses a tracking device is configured to track a location of the probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101]), Venter and Agar do not explicitly disclose that the tracking device is an RF emitter.
Presthus discloses monitoring the position of a medical probe using RF energy waves (“an RF coupling can be used to transmit and receive RF energy waves 151 to monitor the position of the probe relative to the urethral guide” [0093]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe tracking of Venter and Agar with the RF probe tracking of Presthus in order to utilize known probe tracking mechanisms, so as to select a probe tracking mechanism which is most useful to a specific application – for instance, relying on RF tracking when visual tracking of a probe may be obscured or otherwise not preferable.
Regarding claim 6, Venter and Agar disclose the claimed invention except that while Agar discloses a tracking device is configured to track a location of the surgical probe (“The method can also include stereotactically tracking a location of the tip of the sampling probe. The method can further include correlating the report to the tracked location of the tip within an image produced by the imaging procedure” [0101] – “Fluidly integrating all of this information, in a rapid timeframe, should significantly enhance a surgeon's capacity to achieve optimal tumor resection and would provide the foundation for surgery guided by metabolite-imaging mass spectrometry” [0171]), Venter and Agar do not explicitly disclose that the tracking device is an RF emitter.
Presthus discloses monitoring the position of a medical probe using RF energy waves (“an RF coupling can be used to transmit and receive RF energy waves 151 to monitor the position of the probe relative to the urethral guide” [0093]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe tracking of Venter and Agar with the RF probe tracking of Presthus in order to utilize known probe tracking mechanisms, so as to select a probe tracking mechanism which is most useful to a specific application – for instance, relying on RF tracking when visual tracking of a probe may be obscured or otherwise not preferable.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Venter et al. U.S. PGPUB No. 2008/0156985 in view of Agar U.S. PGPUB No. 2016/0341712 in further view of Karancsi et al. U.S. PGPUB No. 2018/0238776.
Regarding claim 11, Venter discloses the claimed invention except that there is no explicit disclosure that the probe is disposable.
Karancsi discloses a surgical [0003] probe for ablating [0323] a tissue [0003] sample for analysis in a mass spectrometer (“Rapid evaporative ionisation mass spectrometry (“REIMS”) may be used for the real time identification of tissues, e.g., during surgical interventions. Coupling of mass spectrometry with a surgical diathermy device has resulted in a sampling technology which has an intra-operative tissue identification accuracy of 92-100%” [0003]), wherein the surgical probe is disposable (“the apparatus may be arranged to have a minimal dead volume thus ensuring fast operation and minimal delay time, to avoid significant memory effects, to have a sufficient trapping volume in order to store the liquid aspirated, e.g., during a surgical intervention, to be easily cleanable and/or to be disposable” [0020]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Venter and Agar with the disposable probe of Karancsi in order to aid in cleanliness of surfaces utilized in a surgical procedure performed with a hand-held sampling probe.
Regarding claim 12, Venter discloses the claimed invention except that there is no explicit disclosure that the probe comprises a collection tip that is ejectable.
Karancsi discloses a surgical [0003] probe for ablating [0323] a tissue [0003] sample for analysis in a mass spectrometer (“Rapid evaporative ionisation mass spectrometry (“REIMS”) may be used for the real time identification of tissues, e.g., during surgical interventions. Coupling of mass spectrometry with a surgical diathermy device has resulted in a sampling technology which has an intra-operative tissue identification accuracy of 92-100%” [0003]), wherein the surgical probe is ejectable (“the apparatus may be arranged to have a minimal dead volume thus ensuring fast operation and minimal delay time, to avoid significant memory effects, to have a sufficient trapping volume in order to store the liquid aspirated, e.g., during a surgical intervention, to be easily cleanable and/or to be disposable” [0020]).
It would have been obvious to one possessing ordinary skill in the art before the effective filing date of the claimed invention to have modified Venter and Agar with the disposable probe of Karancsi in order to aid in cleanliness of surfaces utilized in a surgical procedure performed with a hand-held sampling probe. Further, it has been held that making two items separable requires only routine skill in the art, In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961), see MPEP 2144.04 V.C.
Conclusion
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/JASON L MCCORMACK/Examiner, Art Unit 2881
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