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 .
Response to Arguments
Applicant’s arguments, see page 6, filed 06/26/2026, with respect to the rejection of Claims 37, 41-44, 49-51, 53 and 56 on the grounds of nonstatutory double patenting have been fully considered and are persuasive, as McMichael is not prior art. The rejection of Claims 37, 41-44, 49-51, 53 and 56 on the grounds of nonstatutory double patenting has been withdrawn. However, an updated double patenting rejection in view of Alferness has been made.
Applicant’s arguments, see page 12, filed 06/26/2026, with respect to the rejection(s) of all pending claims under 35 U.S.C. § 103 have been fully considered and are persuasive, as McMichael is not prior art. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Receveur and Alferness. All other prior art rejections have been updated accordingly.
Applicant's arguments filed 06/26/2026 have been fully considered but they are not persuasive.
Regarding the rejection of Claims 44-54 under 35 U.S.C. § 101:
Step 2A, Prong One
The applicant has argued “Claim 44 expressly recites "at least one sensor coupled to the medical instrument" and a processor configured to determine biomarker measurements "via the at least one sensor” when the medical instrument is positioned in first and second airways of a patient anatomy. Those physical, sensor derived measurements from within patient anatomy are not practically performable in the human mind or with pen and paper. The USPTO' s eligibility guidance recognizes that "mental processes" are concepts performed in the human mind, including observations, evaluations, judgments, and opinions. See MPEP § 2106.04(a)(2)(111). But the relevant inquiry is whether the claimed limitation itself can practically be performed in the human mind, and the identified limitations of claim 44 require physical sensing by a component of the claimed medical system.” However, the previous Office Action identified "at least one sensor coupled to the medical instrument" and a processor configured to determine biomarker measurements “via the at least one sensor” as containing the additional elements of a processor and at least one sensor—therefore, the relevant inquiry is not whether the entire claimed limitation can practically be performed in the human mind under Step 2A, Prong One. Although the prepositional phrase “via the at least one sensor” is part of the clause “determining, via the at least one sensor, a first biomarker measurement when the medical instrument is positioned within the first airway”, which recites a judicial exception, the MPEP requires evaluating any additional elements individually and in combination with the recited judicial exception. See MPEP 2106.04(d)(II). The physical, sensor derived measurements from within patient anatomy can be considered an additional element in a claimed process that recites a judicial exception. Finally, the broadest reasonable interpretation of the clause “determining, via the at least one sensor, a first biomarker measurement when the medical instrument is positioned within the first airway” includes observations, evaluations, judgments, and opinions made by a human reading data from the sensor, as the preposition “via” is broadly defined as “by way of”, and any determination made on data originating from a medical instrument positioned within the first airway is included in the claim scope.
The applicant has also argued “Furthermore, the Office Action fails to identify any particular mathematical formula, equation, or calculation recited in claim 44. Although the claim recites a "comparison" of first and second biomarker measurements, it does not recite a mathematical relationship, formula, algorithm, or calculation as such.” However, the previous Office Action never asserted the claim recited mathematical formulas, equations, or calculations (See MPEP 2106.04(a)(2)(I)). Rather, the Office Action asserted the claim recited mental processes that can be performed in the human mind by observations, evaluations, judgments, and opinions, or by a human with the aid of a pen and paper (See MPEP 2106.04(a)(2)(II)).
Step 2A, Prong Two
The Applicant asserts the Office’s analysis is facially improper because it “isolates and only considers "a medical instrument configured to collect a biopsy sample," at least one sensor coupled to the medical instrument," and "a processor configured to."... The claimed system is not merely collecting data and displaying a result; it uses at least one sensor coupled to a medical instrument to obtain biomarker measurements when the medical instrument is positioned within first and second airways of patient anatomy, and then uses those measurements to guide the instrument toward a target to collect a biopsy sample. In particular, the temporal aspect of "determine, via the at least one sensor, a first biomarker measurement when the medical instrument is positioned within a first airway of a patient anatomy" and "determine, via the at least one sensor, a second biomarker measurement when the medical instrument is positioned within a second airway of the patient anatomy" provide meaningful limitations that lead to the processor providing guidance for moving the medical instrument toward a target to collect the biopsy sample... Here, the medical instrument and at least one sensor define how the biomarker measurements are obtained and used to provide guidance for moving the medical instrument toward the target.” However, the Examiner disagrees with the Applicant’s characterization of the invention. Claim 44 does not recite the system using measurements to actively guide the instrument toward a target to collect a biopsy sample. Rather, it recites providing guidance for moving the medical instrument toward a target to collect the biopsy sample —which is itself a judicial exception. An improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. In other words, the improvement in technology cannot come from improvement in the abstract idea. See MPEP 2106.05(a).
The Office Action isolated the elements “a medical instrument configured to collect a biopsy sample," at least one sensor coupled to the medical instrument," and "a processor configured to" because examiners are instructed evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. See MPEP 2106.04(d)(II).
The Applicant has also argued “the processor is claimed as part of a medical system and is configured to use sensor-derived biomarker measurements from a medical instrument positioned within patient anatomy to perform a medical navigation function. This is materially different from claims that simply instruct a generic computer to implement an abstract idea.” The Examiner respectfully disagrees, as a generic computer can be part of a medical system.
Step 2B
The Applicant has reiterated their argument regarding isolating additional elements above and further argued “The cited specification passages of Applicant's specification do not substantiate that the claimed medical system as a whole was well-understood, routine, and conventional. At most, they identify examples of medical instruments and biomarker sensor technologies with no dispositive statement(s) that the examples are well-understood, routine, and conventional. Furthermore, listing examples of medical instruments that could be used and examples of sensors that could be used does not establish that it was well-understood, routine, and conventional to couple at least one sensor to a medical instrument, determine biomarker measurements when the instrument is positioned within different airways of a patient anatomy, compare those biomarker measurements, and provide guidance for moving the medical instrument toward a target to collect a biopsy sample. The eligibility analysis must consider the claim elements individually and as an ordered combination”. In response, the rejection of Claim 44 under 35 U.S.C. § 101 has been updated to provide further evidence that the claimed additional elements and combination of elements in question are well-understood, routine, and conventional.
As stated above, the Office Action isolated the elements “a medical instrument configured to collect a biopsy sample," at least one sensor coupled to the medical instrument," and "a processor configured to" because examiners are instructed evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. See MPEP 2106.04(d)(II).
Finally, Claims 45-51 have been properly addressed under 35 U.S.C. § 101 in the updated rejection.
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 37, 41-44, 49-51, 53 and 56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 6, 10, 16, 25, and 28 of U.S. Patent No. 11,559,357 (Application No. 16/623,260) in view of Alferness et al (US 20110201956 A1, cited in applicant’s IDS, hereinafter Alferness). Although the claims at issue are not identical, they are not patentably distinct from each other because the examined application claims are anticipated by and/or would have been obvious over, the reference claims.
Regarding the claims, 16/623260 discloses:
17/064172
Claim(s)
16/623260
Claim(s)
A method for guiding a medical instrument towards a target, the method comprising:
positioning a medical instrument…, wherein the medical instrument comprises at least one sensor;
determining, via the at least one sensor, a first biomarker measurement …
determining, via the at least one sensor, a second biomarker measurement …; and
based on a comparison of the first biomarker measurement with the second biomarker measurement, providing guidance for moving the medical instrument.
37; 56
A method for guiding a medical instrument towards a target, comprising:
positioning the medical instrument at a first location, wherein the medical instrument comprises at least one sensor;
determining a first biomarker measurement using the at least one sensor;
determining a second biomarker measurement using the at least one sensor;
comparing the first biomarker measurement with the second biomarker measurement to determine a proximity to the target to provide a first comparison; and
providing guidance for moving the medical instrument based on results of the first comparison.
1
positioning a medical instrument within a first airway of a patient anatomy
37; 56
a medical instrument configured to be positioned at a first location within a patient anatomy
16
determining, via the at least one sensor, a first biomarker measurement when the medical instrument is positioned within the first airway
37; 56
wherein the determining the first biomarker measurement includes receiving a first electrical or optical signal from the at least one sensor indicating a first quantity of biomarkers detected at a first location
10
positioning the medical instrument within a second airway of the patient anatomy;
37; 56
wherein the guidance for moving of the medical instrument includes directing retraction, advancement, or steering of the medical instrument towards the target; the at least one sensor is configured to sense a second electrical or optical signal indicating a second quantity of biomarkers detected at a second location
6; 25
determining, via the at least one sensor, a second biomarker measurement when the medical instrument is positioned within the second airway
37; 56
the determining the second biomarker measurement includes receiving a second electrical or optical signal from the at least one sensor indicating a second quantity of biomarkers detected at a second location
10
wherein the guidance for moving the medical instrument includes an indication to further advance the medical instrument through the third airway
41; 49
wherein the guidance for moving of the medical instrument includes directing retraction, advancement, or steering of the medical instrument towards the target
6
wherein the guidance for moving the medical instrument includes an indication to return the medical instrument to the second passageway
42; 50
wherein the guidance for moving of the medical instrument includes directing retraction, advancement, or steering of the medical instrument towards the target
6
wherein the guidance for moving the medical instrument includes an indication to return the medical instrument to the first airway
43; 51
wherein the guidance for moving of the medical instrument includes directing retraction, advancement, or steering of the medical instrument towards the target
6
A medical system, comprising: a medical instrument configured to collect a biopsy sample; at least one sensor coupled to the medical instrument; and a processor configured to: determine, via the at least one sensor, a first biomarker measurement …; determine, via the at least one sensor, a second biomarker measurement …; and based on a comparison of the first biomarker measurement with the second biomarker measurement, provide guidance for moving the medical instrument toward a target to collect the biopsy sample at the target
44
A system, comprising: a medical instrument configured to be positioned at a first location within a patient anatomy; at least one sensor coupled to the medical instrument, the at least one sensor being configured to determine a first biomarker measurement and a second biomarker measurement; and a processor configured to: compare the first biomarker measurement with the second biomarker measurement to determine a proximity to a target within the patient anatomy; and based on the comparing the first biomarker measurement with the second biomarker measurement, provide guidance for moving the medical instrument towards the target.
16
determine, via the at least one sensor, a first biomarker measurement when the medical instrument is positioned within a first airway of a patient anatomy;
44
the at least one sensor is configured to sense a first electrical or optical signal indicating a first quantity of biomarkers detected at a first location
25
determine, via the at least one sensor, a second biomarker measurement when the medical instrument is positioned within a second airway of the patient anatomy
44
to determine the second biomarker measurement, the at least one sensor is configured to sense a second electrical or optical signal indicating a second quantity of biomarkers detected at a second location
25
wherein the first and second biomarker measurements comprise a quantity of volatile organic compounds
53
wherein the first biomarker measurement and the second biomarker measurement are associated with a quantity of volatile organic compounds (VOCs) within the patient anatomy
28
The claims of 16/623260 discloses the claimed invention except for expressly disclosing wherein the passageways are airways, moving the medical instrument based on the guidance for moving the medical instrument (Claims 37 and 56), and provide guidance for moving the medical instrument toward a target to collect the biopsy sample at the target (Claim 44). However, Alferness, which also discloses a method for guiding a medical instrument towards a target ([0011]; [0014]), teaches wherein the passageway is an airway (“The pulmonary diagnostic systems 90 preferably can be configured for use in measuring any a number of characteristics of the lungs. For example, the pulmonary diagnostic systems 90 can be used to measure temperature changes, air flow rates, differences between inhalation and exhalation air velocities, magnitudes of air flow and/or velocity in a single direction in an airway, concentrations of a specific component or of specific components of a measured fluid (e.g., oxygen concentration) and the like”, [0033]; “the catheter can be compatible for use with flexible bronchoscopy, which allows a doctor to examine an inside of a patient's airway and lungs for abnormalities, such as foreign bodies, bleeding, tumors, or inflammation, for example but without limitation”, [0036]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of the claims of 16/623260 such that the passageway of interest is an airway, because a need exists for an efficient system and manner to locate regions of the lung that would benefit from the placement of treatment devices (See [0011] of Alferness) and diagnostic devices (See [0036] of Alferness).
It has been held that optimizations within prior art conditions or through routine experimentation is obvious. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II). It is well known that the purpose of providing guidance for moving a medical instrument is to move the medical instrument based on that guidance and perform the function of that medical instrument in the appropriate area. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify claims of 16/623260 and add a step reciting “moving the medical instrument based on the guidance for moving the medical instrument” to Claims 37 and 56 and “provide guidance for moving the medical instrument toward a target to collect the biopsy sample at the target” to Claim 44.
Claim Rejections - 35 USC § 101
Claims 44-54 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding Claim 44, the claim recites a medical system. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
determine, via the at least one sensor, a first biomarker measurement when the medical instrument is positioned within a first airway of a patient anatomy
determine, via the at least one sensor, a second biomarker measurement when the medical instrument is positioned within a second airway of the patient anatomy
based on a comparison of the first biomarker measurement with the second biomarker measurement, provide guidance for moving the medical instrument toward a target to collect the biopsy sample at the target
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is capable of manually/mentally providing guidance for moving the medical instrument toward a target to collect the biopsy sample at the target, based on a comparison of the first biomarker measurement with the second biomarker measurement, e.g. using voice, pointing, or pen and paper.
The plain meaning of the limitation “determine, via the at least one sensor, a first biomarker measurement when the medical instrument is positioned within a first airway of a patient anatomy” includes mental processes that can be performed in the human mind by observations, evaluations, judgments, and opinions, or by a human with the aid of a pen and paper, or using a generic computer as a tool to perform these mental process steps in real time.
The plain meaning of the limitation “determine, via the at least one sensor, a second biomarker measurement when the medical instrument is positioned within a second airway of the patient anatomy” includes mental processes that can be performed in the human mind by observations, evaluations, judgments, and opinions, or by a human with the aid of a pen and paper, or using a generic computer as a tool to perform these mental process steps in real time.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
a medical instrument configured to collect a biopsy sample
at least one sensor coupled to the medical instrument
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
a processor configured to
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
a medical instrument configured to collect a biopsy sample
at least one sensor coupled to the medical instrument
a processor configured to
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The medical instrument configured to collect a biopsy sample is considered to be well-understood, routine, and conventional based on statement from Householder et al (US 20180116644 A1) (“Biopsy samples have been obtained in a variety of ways in various medical procedures including open and percutaneous methods using a variety of devices”, [0002]; [0005] and [0006] disclose a list of known medical instruments configured to collect biopsy samples).
The sensor attached to the medical instrument is considered to be well-understood, routine, and conventional based on a statement from Brown et al (US 20160000414 A1) (See [0005]-[0008]).
The processor is considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 12/09/2022 (See [0030], [0103]-[0104]).
Dependent Claim 45 also fails to add subject matter qualifying as significantly more to the abstract independent claims as “wherein the second airway is a next generation airway to the first airway” merely recites additional judicial exception(s).
Dependent Claim 46 also fails to add subject matter qualifying as significantly more to the abstract independent claims as it merely further limits the abstract idea (“determine, via the at least one sensor, a third biomarker measurement when the medical instrument is positioned within a third airway of the patient anatomy, wherein the guidance for moving the medical instrument is further based on a comparison of the second biomarker measurement with the third biomarker measurement”), recites limitations that do not integrate the claims into a practical application (“wherein the processor is further configured to...”), and does not recite significantly more than the identified abstract idea (“wherein the processor is further configured to...”).
Dependent Claim 47 also fails to add subject matter qualifying as significantly more to the abstract independent claims as “wherein the guidance for moving the medical instrument is further based on a comparison of the first biomarker measurement with the third biomarker measurement” merely recites additional judicial exception(s).
Dependent Claim 48 also fails to add subject matter qualifying as significantly more to the abstract independent claims as “wherein the third airway is a next generation airway to the first airway and the third airway is a different airway from the second airway” merely limits the judicial exception(s) recited in parent Claim 44.
Dependent Claim 49 also fails to add subject matter qualifying as significantly more to the abstract independent claims as “wherein the guidance for moving the medical instrument includes an indication to further advance the medical instrument through the third airway” merely recites additional judicial exception(s).
Dependent Claim 50 also fails to add subject matter qualifying as significantly more to the abstract independent claims as “wherein the guidance for moving the medical instrument includes an indication to return the medical instrument to the second airway” merely recites additional judicial exception(s).
Dependent Claim 51 also fails to add subject matter qualifying as significantly more to the abstract independent claims as “wherein the guidance for moving the medical instrument includes an indication to return the medical instrument to the first airway” merely recites additional judicial exception(s).
Dependent Claim 53 also fails to add subject qualifying as significantly more to the abstract independent claims as it recites limitations that do not integrate the claims into a practical application and does not recite significantly more than the identified abstract idea (“wherein the first and second biomarker measurements comprise a quantity of volatile organic compounds” qualifies as mere data gathering).
Dependent Claim 54 also fails to add subject qualifying as significantly more to the abstract independent claims as it recites limitations that do not integrate the claims into a practical application and does not recite significantly more than the identified abstract idea (“wherein the first and second biomarker measurements comprise at least one of a pressure, an oxygen level, or a pH level” qualifies as mere data gathering).
Therefore, Claims 44-51 and 53-54 are not patent eligible under 35 U.S.C. § 101.
The Examiner notes Claim 52 is not currently rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 37-39, 41-47, 49-51 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Receveur et al (US 20050165324 A1, hereinafter Receveur) in view of Alferness et al (US 20110201956 A1, cited in applicant’s IDS, hereinafter Alferness).
Regarding Claim 37, Receveur discloses a method for guiding a medical instrument (Element 10, Fig. 1; “The lead 10 may include various pull wires, a stylet may [be] disposed within the lead 10, the lead 10 may pass over a guidewire, or the lead may be disposed within a catheter or incorporate various other known manipulation devices. In its most basic sense and as used herein, lead 10 is illustrative of any device that can be passed into and guided within the right atrium and then detect and/or enter the coronary sinus, such as, for example, a sensing/pacing/defibrillation lead, a catheter, a stylet, a guidewire, or various other medical delivery or surgical instruments”, [0024]) towards a target ( “the present invention relates to a system and method for locating a specific anatomical position”, [0001]), the method comprising:
positioning the medical instrument within a first passageway of a patient anatomy (“the lead 10 is guided into the right atrium…”, [0030]), wherein the medical instrument comprises at least one sensor (Element 14, Fig. 1; “FIG. 1 illustrates a lead 10 having a sensor 14 disposed at or near a distal end of the lead 10. The lead 10 has a lead body 12 that carries the sensor 14 and can be manipulated for movement and steerability within the cardiac anatomy”, [0024]; “In one embodiment, the sensor 14 is a temperature sensor. In another embodiment, the sensor 14 is for example, a pressures sensor, an oxygen sensor, a chemical sensor (e.g., lactate), senses PH balance, is a velocity sensor that senses flow, is an ultrasound sensor (with or without Doppler capability), or is an optical sensor”, [0026]);
determining, via the at least one sensor, a first biomarker measurement when the medical instrument is positioned within the first passageway (“the lead 10 is guided into the right atrium and the sensor 14 provides data to an external device”, [0030]);
positioning the medical instrument within a second passageway of the patient anatomy (“The present invention, in one embodiment is a system and method that provides for the guidance of a device to the ostium of the coronary sinus”, [0022]);
determining, via the at least one sensor, a second biomarker measurement when the medical instrument is positioned within the second passageway (“As the sensor 14 approaches the ostium of the coronary sinus 32, the temperatures rises linearly, proportional to distance. When the sensor 14 enters the ostium 32, the temperature is constant and is represented as such. Of course, this temperature value is elevated from that of the right atrium 36”, [0035]);
based on a comparison of the first biomarker measurement with the second biomarker measurement, providing guidance for moving the medical instrument (“The processor 58 takes the various data available to provide a useful navigational result to the physician 62. The navigational display 60 provides meaningful visual and/or audio output that assists the physician in navigating a device, such as lead 10, within the anatomy of the patient. For example, the navigation display 60 assists the physician 62 in finding and/or confirming entry into the coronary sinus”, [0044]); and
moving the medical instrument based on the guidance for moving the medical instrument (“a graphical model or map is illustrated on a screen with a representation of the current sensor 14 position and the mapped anatomical features that are known, such as the coronary sinus 32. The physician then navigates based on this generated map”, [0039]).
Receveur discloses the claimed invention except for expressly disclosing wherein the passageway is an airway. However, Alferness, which also discloses a method for guiding a medical instrument towards a target ([0011]; [0014]), teaches wherein the passageway is an airway (The pulmonary diagnostic systems 90 preferably can be configured for use in measuring any a number of characteristics of the lungs. For example, the pulmonary diagnostic systems 90 can be used to measure temperature changes, air flow rates, differences between inhalation and exhalation air velocities, magnitudes of air flow and/or velocity in a single direction in an airway, concentrations of a specific component or of specific components of a measured fluid (e.g., oxygen concentration) and the like”, [0033]; “the catheter can be compatible for use with flexible bronchoscopy, which allows a doctor to examine an inside of a patient's airway and lungs for abnormalities, such as foreign bodies, bleeding, tumors, or inflammation, for example but without limitation”, [0036]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of Receveur such that the passageway of interest is an airway instead of a cardiac passageway, because a need exists for an efficient system and manner to locate regions of the lung that would benefit from the placement of treatment devices (See [0011] of Alferness) and diagnostic devices (See [0036] of Alferness).
Regarding Claim 38, modified Receveur discloses the method of claim 37. Modified Receveur discloses the claimed invention except for expressly disclosing wherein the second passageway is a next generation passageway to the first passageway. However, Alferness teaches wherein the second passageway is a next generation airway to the first airway (“The flexible bronchoscope can take the form of a long thin tube that contains small clear fibers that transmit light images while the tube bends for navigation of the tortuous bends present in lung air passageways. The flexibility of the instrument allows the instrument to provide readings from very distal locations within an airway”, [0036]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of Receveur such that the passageway of interest is an airway instead of a cardiac passageway and wherein the second airway is a next generation airway to the first airway, because a need exists for an efficient system and manner to locate regions of the lung that would benefit from the placement of treatment devices (See [0011] of Alferness) and diagnostic devices (See [0036] of Alferness).
Regarding Claim 39, modified Receveur discloses the claimed method of claim 38, further comprising:
positioning the medical instrument within a third airway of the patient anatomy (“In summary, a lead is advanced into the right atrium and caused to enter the coronary sinus”, [0005]; the examiner notes that under broadest reasonable interpretation, the ostium to the coronary sinus can be considered a second passageway and the coronary sinus can be considered a third passageway; the modification of Receveur with Alferness above wherein the passageway is modified to be an airway also applies to this limitation);
determining, via the at least one sensor, a third biomarker measurement when the medical instrument is positioned within the third airway (“The sensor 14 may sense any criteria useful for locating the coronary sinus and/or confirming that the sensor 14 is disposed within the coronary sinus”, [0026]; the modification of Receveur with Alferness above wherein the passageway is modified to be an airway also applies to this limitation); and
based on a comparison of the second biomarker measurement with the third biomarker measurement, providing guidance for moving the medical instrument (“The processor 58 takes the various data available to provide a useful navigational result to the physician 62. The navigational display 60 provides meaningful visual and/or audio output that assists the physician in navigating a device, such as lead 10, within the anatomy of the patient. For example, the navigation display 60 assists the physician 62 in finding and/or confirming entry into the coronary sinus”, [0044]; the modification of Receveur with Alferness above wherein the passageway is modified to be an airway also applies to this limitation).
Regarding Claim 40, modified Receveur discloses the method of claim 39. Modified Receveur discloses the claimed invention except for expressly disclosing wherein the third airway is a next generation airway to the first airway and the third airway is a different airway from the second airway. However, Alferness teaches navigating to next generation airways from a primary airway (“The flexible bronchoscope can take the form of a long thin tube that contains small clear fibers that transmit light images while the tube bends for navigation of the tortuous bends present in lung air passageways. The flexibility of the instrument allows the instrument to provide readings from very distal locations within an airway”, [0036]). Furthermore, it has been held that optimizations within prior art conditions or through routine experimentation is obvious. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II). It is well known that next generation airways from a primary airway in the lungs include multiple next generation airways. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Receveur with Alferness such that the third airway is a next generation airway to the first airway and the third airway is a different airway from the second airway, because a need exists for an efficient system and manner to locate regions of the lung that would benefit from the placement of treatment devices (See [0011] of Alferness) and diagnostic devices (See [0036] of Alferness).
Regarding Claim 41, modified Receveur disclose the method of claim 39, wherein the guidance for moving the medical instrument includes an indication to further advance the medical instrument through the third airway (“a graphical model or map is illustrated on a screen with a representation of the current sensor 14 position and the mapped anatomical features that are known, such as the coronary sinus 32. The physician then navigates based on this generated map. Alternatively, or in addition to the graphical mapping features, audible commands can be generated based on the processed data. For example, commands such as "advance," "retract," "rotate X degrees," etc. are generated by the processor”, [0039]; the modification of Receveur with Alferness above wherein the passageway is modified to be an airway also applies to this limitation).
Regarding Claim 42, modified Receveur discloses the method of claim 39, wherein the guidance for moving the medical instrument includes an indication to return the medical instrument to the second(“a graphical model or map is illustrated on a screen with a representation of the current sensor 14 position and the mapped anatomical features that are known, such as the coronary sinus 32. The physician then navigates based on this generated map. Alternatively, or in addition to the graphical mapping features, audible commands can be generated based on the processed data. For example, commands such as "advance," "retract," "rotate X degrees," etc. are generated by the processor”, [0039]; the modification of Receveur with Alferness above wherein the passageway is modified to be an airway also applies to this limitation).
Regarding Claim 43, modified Receveur discloses the method of claim 39, wherein the guidance for moving the medical instrument includes an indication to return the medical instrument to the first airway (“a graphical model or map is illustrated on a screen with a representation of the current sensor 14 position and the mapped anatomical features that are known, such as the coronary sinus 32. The physician then navigates based on this generated map. Alternatively, or in addition to the graphical mapping features, audible commands can be generated based on the processed data. For example, commands such as "advance," "retract," "rotate X degrees," etc. are generated by the processor”, [0039]; the modification of Receveur with Alferness above wherein the passageway is modified to be an airway also applies to this limitation).
Claims 44-52, 54, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Receveur in view of Alferness, and further in view of Fenech et al (US 20130096385 A1, cited in applicant IDS, hereinafter Fenech).
Regarding Claim 44, Receveur discloses a medical system (See Figs. 1 and 11), comprising:
a medical instrument (Element 10, Fig. 1; “The lead 10 may include various pull wires, a stylet may [be] disposed within the lead 10, the lead 10 may pass over a guidewire, or the lead may be disposed within a catheter or incorporate various other known manipulation devices. In its most basic sense and as used herein, lead 10 is illustrative of any device that can be passed into and guided within the right atrium and then detect and/or enter the coronary sinus, such as, for example, a sensing/pacing/defibrillation lead, a catheter, a stylet, a guidewire, or various other medical delivery or surgical instruments”, [0024]);
at least one sensor coupled to the medical instrument (Element 14, Fig. 1; “FIG. 1 illustrates a lead 10 having a sensor 14 disposed at or near a distal end of the lead 10. The lead 10 has a lead body 12 that carries the sensor 14 and can be manipulated for movement and steerability within the cardiac anatomy”, [0024]); and
a processor (Element 18, Fig. 1; “Alternatively, or in addition thereto, navigation control display 18 processes the data and then displays or presents guidance information”, [0025]) configured to:
determine, via the at least one sensor, a first biomarker measurement when the medical instrument is positioned within a first passageway of a patient anatomy (“the lead 10 is guided into the right atrium and the sensor 14 provides data to an external device”, [0030]);
determine, via the at least one sensor, a second biomarker measurement when the medical instrument is positioned within a second passageway of the patient anatomy (“As the sensor 14 approaches the ostium of the coronary sinus 32, the temperatures rises linearly, proportional to distance. When the sensor 14 enters the ostium 32, the temperature is constant and is represented as such. Of course, this temperature value is elevated from that of the right atrium 36”, [0035]); and
based on a comparison of the first biomarker measurement with the second biomarker measurement, provide guidance for moving the medical instrument (“The processor 58 takes the various data available to provide a useful navigational result to the physician 62. The navigational display 60 provides meaningful visual and/or audio output that assists the physician in navigating a device, such as lead 10, within the anatomy of the patient. For example, the navigation display 60 assists the physician 62 in finding and/or confirming entry into the coronary sinus”, [0044]).
Receveur discloses the claimed invention except for expressly disclosing wherein the medical instrument configured to collect a biopsy sample;
wherein the passageway is an airway; and
the processor is configured to: provide guidance for moving the medical instrument toward a target to collect the biopsy sample at the target.
However, Alferness, which also discloses a method for guiding a medical instrument towards a target ([0011]; [0014]), teaches wherein the passageway is an airway (“The pulmonary diagnostic systems 90 preferably can be configured for use in measuring any a number of characteristics of the lungs. For example, the pulmonary diagnostic systems 90 can be used to measure temperature changes, air flow rates, differences between inhalation and exhalation air velocities, magnitudes of air flow and/or velocity in a single direction in an airway, concentrations of a specific component or of specific components of a measured fluid (e.g., oxygen concentration) and the like”, [0033]; “the catheter can be compatible for use with flexible bronchoscopy, which allows a doctor to examine an inside of a patient's airway and lungs for abnormalities, such as foreign bodies, bleeding, tumors, or inflammation, for example but without limitation”, [0036]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of Receveur such that the passageway of interest is an airway instead of a cardiac passageway, because a need exists for an efficient system and manner to locate regions of the lung that would benefit from the placement of treatment devices (See [0011] of Alferness) and diagnostic devices (See [0036] of Alferness).
Fenech, which also discloses a medical system configured to move through passageways of the patient anatomy (See Abstract) teaches wherein the medical instrument is configured to collect a biopsy sample at a target (“Other probe systems that may be used include, but are not limited to, biopsy forceps, biopsy needles, biopsy brushes, ablation lasers, treatment brushes, and radial ultrasound probes”, [0031]) and the processor is configured to: provide guidance for moving the medical instrument toward a target to collect the biopsy sample at the target (“As noted above, steerable segment 116 of catheter 110 can be remotely steered, and vision probe 400 can provide video of the respiratory tract that helps a user when navigating catheter 110 toward a target work site”, [0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add biopsy sampling to the capabilities of the medical instrument of modified Receveur, as taught by Fenech, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Regarding Claim 45, modified Receveur discloses the medical system of claim 44. Modified Receveur discloses the claimed invention except for expressly disclosing wherein the second airway is a next generation airway to the first airway. However, Alferness teaches wherein the second passageway is a next generation airway to the first airway (“The flexible bronchoscope can take the form of a long thin tube that contains small clear fibers that transmit light images while the tube bends for navigation of the tortuous bends present in lung air passageways. The flexibility of the instrument allows the instrument to provide readings from very distal locations within an airway”, [0036]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of Receveur such that the passageway of interest is an airway instead of a cardiac passageway and wherein the second airway is a next generation airway to the first airway, because a need exists for an efficient system and manner to locate regions of the lung that would benefit from the placement of treatment devices (See [0011] of Alferness) and diagnostic devices (See [0036] of Alferness).
Regarding Claim 46, modified Receveur discloses the medical system of claim 45, wherein the processor is further configured to:
determine, via the at least one sensor, a third biomarker measurement when the medical instrument is positioned within a third airway of the patient anatomy (“The sensor 14 may sense any criteria useful for locating the coronary sinus and/or confirming that the sensor 14 is disposed within the coronary sinus”, [0026]; the examiner notes that under broadest reasonable interpretation, the ostium to the coronary sinus can be considered a second passageway and the coronary sinus can be considered a third passageway; the modification of Receveur with Alferness above wherein the passageway is modified to be an airway also applies to this limitation), wherein the guidance for moving the medical instrument is further based on a comparison of the second biomarker measurement with the third biomarker measurement (“The processor 58 takes the various data available to provide a useful navigational result to the physician 62. The navigational display 60 provides meaningful visual and/or audio output that assists the physician in navigating a device, such as lead 10, within the anatomy of the patient. For example, the navigation display 60 assists the physician 62 in finding and/or confirming entry into the coronary sinus”, [0044]; the modification of Receveur with Alferness above wherein the passageway is modified to be an airway also applies to this limitation).
Regarding Claim 47, modified Receveur discloses the medical system of claim 46, wherein the guidance for moving the medical instrument is further based on a comparison of the first biomarker measurement with the third biomarker measurement (“The processor 58 takes the various data available to provide a useful navigational result to the physician 62. The navigational display 60 provides meaningful visual and/or audio output that assists the physician in navigating a device, such as lead 10, within the anatomy of the patient. For example, the navigation display 60 assists the physician 62 in finding and/or confirming entry into the coronary sinus”, [0044]; the modification of Receveur with Alferness above wherein the passageway is modified to be an airway also applies to this limitation).
Regarding Claim 48, modified Receveur discloses the medical system of claim 46. Modified Receveur discloses the claimed invention except for expressly disclosing wherein the third airway is a next generation airway to the first airway and the third(“The flexible bronchoscope can take the form of a long thin tube that contains small clear fibers that transmit light images while the tube bends for navigation of the tortuous bends present in lung air passageways. The flexibility of the instrument allows the instrument to provide readings from very distal locations within an airway”, [0036]). Furthermore, it has been held that optimizations within prior art conditions or through routine experimentation is obvious. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II). It is well known that next generation airways from a primary airway in the lungs include multiple next generation airways. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Receveur with Alferness such that the third airway is a next generation airway to the first airway and the thirdof the lung that would benefit from the placement of treatment devices (See [0011] of Alferness) and diagnostic devices (See [0036] of Alferness).
Regarding Claim 49, Receveur discloses the medical system of claim 46, wherein the guidance for moving the medical instrument includes an indication to further advance the medical instrument through the third airway (“a graphical model or map is illustrated on a screen with a representation of the current sensor 14 position and the mapped anatomical features that are known, such as the coronary sinus 32. The physician then navigates based on this generated map. Alternatively, or in addition to the graphical mapping features, audible commands can be generated based on the processed data. For example, commands such as "advance," "retract," "rotate X degrees," etc. are generated by the processor”, [0039]; the modification of Receveur with Alferness above wherein the passageway is modified to be an airway also applies to this limitation).
Regarding Claim 50, modified Receveur discloses the medical system of claim 46, wherein the guidance for moving the medical instrument includes an indication to return the medical instrument to the second(“a graphical model or map is illustrated on a screen with a representation of the current sensor 14 position and the mapped anatomical features that are known, such as the coronary sinus 32. The physician then navigates based on this generated map. Alternatively, or in addition to the graphical mapping features, audible commands can be generated based on the processed data. For example, commands such as "advance," "retract," "rotate X degrees," etc. are generated by the processor”, [0039]; the modification of Receveur with Alferness above wherein the passageway is modified to be an airway also applies to this limitation).
Regarding Claim 51, Receveur discloses the medical system of claim 46, wherein the guidance for moving the medical instrument includes an indication to return the medical instrument to the first(“a graphical model or map is illustrated on a screen with a representation of the current sensor 14 position and the mapped anatomical features that are known, such as the coronary sinus 32. The physician then navigates based on this generated map. Alternatively, or in addition to the graphical mapping features, audible commands can be generated based on the processed data. For example, commands such as "advance," "retract," "rotate X degrees," etc. are generated by the processor”, [0039]).
Regarding Claim 52, modified Receveur discloses the medical system of claim 44. Modified Receveur discloses the claimed invention except for expressly disclosing wherein the processor is further configured to instruct one or more actuators to automatically move the medical instrument based on the guidance. However, Fenech teaches wherein the processor is further configured to instruct one or more actuators (Element 122, Fig. 1) to automatically move the medical instrument (“Drive interfaces 120 of FIG. 1, which pulls on tendons 230 to actuate steerable segment 116, includes a mechanical system or transmission 124 that converts the movement of actuators 122, e.g., electric motors, into movements of (or tensions in) tendons 230 that run through catheter 110 and connect to steerable segment 116”, [0019]) based on the guidance (“Control logic 140 controls the actuators in drive interface 120 to selectively pull on the tendons as needed to actuate and steer steerable segment 116. In general, control logic 140 operates in response to commands from a user, e.g., a surgeon or other medical personnel using operator interface 150, and in response to measurement signals from sensor system 160. However, in holding modes as described further below, control logic 140 operates in response to measurement signals from sensor system 160 to maintain or acquire a previously identified working configuration”, [0021]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the actuators that automatically move the medical instrument based on the guidance as taught by Fenech to the system of modified Receveur, because actuators can be both useful and necessary with medical probes (See Abstract of Fenech).
Regarding Claim 54, modified Receveur discloses the medical system of claim 44, wherein the first and second biomarker measurements comprise at least one of a pressure, an oxygen level, or a pH level (“In another embodiment, the sensor 14 is for example, a pressures sensor, an oxygen sensor, a chemical sensor (e.g., lactate), senses PH balance”, [0026]; “FIGS. 5A-5E represent one embodiment wherein sensor data, such as temperature data, may be used to map a portion of the right atrium 36 and/or navigate within the right atrium 36. Other physical parameters such as oxygen content, pressure, velocity, or the like may be used in a similar manner”, [0036]).
Regarding Claim 56, Receveur discloses a method for guiding a medical instrument (Element 10, Fig. 1; “The lead 10 may include various pull wires, a stylet may [be] disposed within the lead 10, the lead 10 may pass over a guidewire, or the lead may be disposed within a catheter or incorporate various other known manipulation devices. In its most basic sense and as used herein, lead 10 is illustrative of any device that can be passed into and guided within the right atrium and then detect and/or enter the coronary sinus, such as, for example, a sensing/pacing/defibrillation lead, a catheter, a stylet, a guidewire, or various other medical delivery or surgical instruments”, [0024]) towards a target ( “the present invention relates to a system and method for locating a specific anatomical position”, [0001]), the method comprising:
positioning a medical instrument within a first passageway of a patient anatomy (“the lead 10 is guided into the right atrium…”, [0030]), wherein the medical instrument comprises at least one sensor (Element 14, Fig. 1; “FIG. 1 illustrates a lead 10 having a sensor 14 disposed at or near a distal end of the lead 10. The lead 10 has a lead body 12 that carries the sensor 14 and can be manipulated for movement and steerability within the cardiac anatomy”, [0024]);
determining, via the at least one sensor, a first biomarker measurement when the medical instrument is positioned within the first passageway (“the lead 10 is guided into the right atrium and the sensor 14 provides data to an external device”, [0030]);
positioning the medical instrument within a second passageway of the patient anatomy (“The present invention, in one embodiment is a system and method that provides for the guidance of a device to the ostium of the coronary sinus”, [0022]);
determining, via the at least one sensor, a second biomarker measurement when the medical instrument is positioned within the second passageway (“As the sensor 14 approaches the ostium of the coronary sinus 32, the temperatures rises linearly, proportional to distance. When the sensor 14 enters the ostium 32, the temperature is constant and is represented as such. Of course, this temperature value is elevated from that of the right atrium 36”, [0035]); and
based on a comparison of the first biomarker measurement with the second biomarker measurement, providing guidance for moving the medical instrument (“The processor 58 takes the various data available to provide a useful navigational result to the physician 62. The navigational display 60 provides meaningful visual and/or audio output that assists the physician in navigating a device, such as lead 10, within the anatomy of the patient. For example, the navigation display 60 assists the physician 62 in finding and/or confirming entry into the coronary sinus”, [0044]); and
moving the medical instrument based on the guidance for moving the medical instrument (“a graphical model or map is illustrated on a screen with a representation of the current sensor 14 position and the mapped anatomical features that are known, such as the coronary sinus 32. The physician then navigates based on this generated map”, [0039]).
Receveur discloses the claimed invention except for expressly disclosing a non-transitory machine-readable medium comprising a plurality of machine- readable instructions which when executed by one or more processors associated with a medical device are adapted to cause the one or more processors to perform the method; and
wherein the passageway is an airway.
However, Fenech teaches a non-transitory machine-readable medium comprising a plurality of machine- readable instructions (“Some embodiments or elements of the above invention can be implemented in a computer-readable media, e.g., a non-transient media, such as an optical or magnetic disk, a memory card, or other solid state storage containing instructions that a computing device can execute to perform specific processes that are described herein”, [0047]) which when executed by one or more processors associated with a medical device are adapted to cause the one or more processors to perform the method ([0021],-[0022], [0045]-[0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the non-transitory machine-readable medium comprising a plurality of machine- readable instructions which when executed by one or more processors associated with a medical device are adapted to cause the one or more processors to perform the method of Fenech to the method of Receveur, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Alferness, which also discloses a method for guiding a medical instrument towards a target ([0011]; [0014]), teaches wherein the passageway is an airway (The pulmonary diagnostic systems 90 preferably can be configured for use in measuring any a number of characteristics of the lungs. For example, the pulmonary diagnostic systems 90 can be used to measure temperature changes, air flow rates, differences between inhalation and exhalation air velocities, magnitudes of air flow and/or velocity in a single direction in an airway, concentrations of a specific component or of specific components of a measured fluid (e.g., oxygen concentration) and the like”, [0033]; “the catheter can be compatible for use with flexible bronchoscopy, which allows a doctor to examine an inside of a patient's airway and lungs for abnormalities, such as foreign bodies, bleeding, tumors, or inflammation, for example but without limitation”, [0036]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of Receveur such that the passageway of interest is an airway instead of a cardiac passageway, because a need exists for an efficient system and manner to locate regions of the lung that would benefit from the placement of treatment devices (See [0011] of Alferness) and diagnostic devices (See [0036] of Alferness).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Receveur in view of Alferness and Fenech, and further in view of the Non-Patent Literature (NPL) to Ashley et al (“Measurement of Volatile Organic Compounds in Human Blood”, hereinafter Ashley).
Regarding Claim 53, modified Receveur discloses the medical system of claim 44. Modified Receveur discloses the claimed invention except for expressly disclosing wherein the first and second biomarker measurements comprise a quantity of volatile organic compounds. Rather, Receveur discloses wherein the first biomarker measurements can be temperature, oxygen, a chemical (e.g., lactate), pH, flow velocity, optical measurements, or ultrasound measurements in blood ([0026]). However, Ashley teaches the need to sense volatile organic compounds in blood (“Measurement of Volatile Organic Compounds in Human Blood”, Title; “and others, there is ample reason for concern about the toxicity of VOCs in spite of the lack of understanding about morbidity and mortality resulting from low-level exposure”, p. 871, col. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add volatile organic compounds to the list of biomarkers sensed by modified Receveur, because there is a need to sense and understand the role that volatile organic compounds play in various diseases and symptoms (See entire Introduction and Conclusion Sections of Ashley).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Delgado Alonso et al (US 20180360353 A1).
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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