Detailed Action
This is in response to the amendment filed 05/04/2026
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.
Claim(s) 52-54, 56, 57, 60-64, 66, 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0088457 (Johnson) in view of U.S. Patent Publication Number 2016/0354056 (Signh et al.), U.S. Patent Publication Number 2018/0065248 (Barrai et al.)
Regarding claims 52-54, 66, 67 Johnson discloses as shown in Figures 6-8, a medical system for performing a minimally invasive procedure within an anatomic passageway, the system comprising: an outer catheter (catheter 22, see paragraph [0052]) comprising one or more first lumens; an inner instrument (tool 40, see paragraph [0054]) configured to be slideably deployed through one of the one or more first lumens, a sealing device (balloon 24, see paragraph [0052]) coupled to the outer catheter, the sealing device comprises one or more balloons
Johnson fails to disclose one or more first sensors; and a control system configured to detect one of more anatomical features beyond a surface of an anatomical passage in which at least one of the outer catheter or inner instrument is positioned, a manipulator assembly configured to control movement of at least one of the outer catheter or the inner instrument.
Signh et al., from the same filed of endeavor teaches a similar medical system as shown in Figures 3-5, 26, where the system one or more first sensors; and a control system capable of detecting one of more anatomical features beyond a surface of an anatomical passage in which at least one of an outer catheter or inner instrument is positioned, where the one or more anatomical features include at least one target tissue, for the purpose of knowing where an area of the body is the surgeon would like to avoid. See paragraph [0108].
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 system disclosed by system disclosed by Johnson to include the one or more first sensors; and a control system configured to detect one of more anatomical features beyond a surface of an anatomical passage in which at least one of the outer catheter or inner instrument is positioned taught by Signh et al. in order to know where an area of the body is the surgeon would like to avoid.
Barrai et al., from the same field of endeavor teaches a similar system, with a manipulator assembly configured to control movement of at least one of an outer catheter or the inner instrument, and a control system, where the control system capable of controlling the manipulator to disable the advancement of an inner instrument based on one or more fist sensors detecting the one or more anatomical features. See paragraphs [0019], [0021], [0022].
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 system disclosed by Johnson in view of Signh et al. to modify the control system such that it was capable of controlling the manipulator to disable the advancement of the inner instrument based on one or more fist sensors detecting the one or more anatomical features as taught by Barrai et al. in order avoid an area of the body the surgeon does not want the instrument to go.
Regarding claims 56, 57 Johnson discloses the inner instrument has a distal end (tissue sampling device 640, see paragraph [0059]) shaped capable of penetrating a surface of the anatomic passageway at a point of entry, where the inner instrument is a biopsy device. See paragraph [0058]
Regarding claims 60, 61 Johnson in view of Signh et al. discloses wherein the one or more first sensors comprise at least one of an imaging sensor, a Doppler OCT device, or a Doppler ultrasound device, where the imaging sensor comprises an OCT device. See paragraph [0108] of Signh et al.
Regarding claim 62, 63 Johnson in view of Signh et al. fail to disclose the one or more first sensors are mounted to the inner instrument or the outer catheter.
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 system disclosed by Johnson in view of Signh et al. to rearrange the location of the one or more first sensors such that they were mounted to the inner instrument or the outer catheter because it would only require a rearrangement of parts without changing how the device operates (the sensors would still detect parts of the anatomy). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 64, Johnson in view of Signh et al. discloses one or more second sensors configured to detect bleeding into the anatomic passageway from outside the anatomic passageway. See paragraph [0108] of Signh et al. disclosing the sensor is part of an OCT device which is described by the applicant in paragraph [0048] their specification as configured to detect bleeding into the anatomic passageway from outside the anatomic passageway.
Claim(s) 55, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0088457 (Johnson) in view of U.S. Patent Publication Number 2016/0354056 (Signh et al.), U.S. Patent Publication Number 2018/0065248 (Barrai et al.) as applied to claim 52 above, and further in view of U.S. Patent Publication Number 2013/0030363 (Wong et al.)
Regarding claim 55, Johnson in view of Signh, and Barrai fail to disclose wherein at least one of the outer catheter or the inner instrument further comprises a tracking system, wherein the tracking system includes at least one of a fiber optic shape sensor or an EM sensor.
Wong et al. et al., from the same field of endeavor teaches a similar system as shown in Figure 2 where at least one of the outer catheter or the inner instrument further comprises a tracking system, wherein the tracking system includes at least one of a fiber optic shape sensor (see paragraph [0050]) for the purpose of obtaining accurate shape and position measurements of the catheter. See paragraph [0050].
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 system disclosed by Johnson in view of Signh, and Barrai to include the fiber optic shape sensor in the outer catheter, in order to obtain accurate shape and position measurements of the catheter.
Claim(s) 58, 59, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0088457 (Johnson) in view of U.S. Patent Publication Number 2016/0354056 (Signh et al.), U.S. Patent Publication Number 2018/0065248 (Barrai et al.) as applied to claim 52 above, and further in view of U.S. Patent Number 5,687,739 (McPherson et al.)
Regarding claims 58, 59 Johnson in view of Signh, and Barrai fail to disclose wherein the inner instrument comprises one or more second lumens, wherein a working instrument is configured to be slideably received through the one or more second lumen, wherein the inner instrument or the working instrument comprises a dilation device for expanding an opening in a surface of the anatomic passageway at a point of entry.
McPherson, from the same field of endeavor teaches a similar medical system as shown in Figures 3-10, where an inner instrument comprises a lumen with a working instrument (dilator 12, 112) slideably received through the one or more lumen, wherein the inner instrument or the working instrument comprises a dilation device for expanding an opening in a surface of the anatomic passageway at a point of entry, for the purpose of facilitating positioning of a piercing tip of a biopsy device. See col. 6, lines 40-64.
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 medical system disclosed by Johnson in view of Signh, and Barrai to include a second lumen in the inner instrument and the working instrument slidably received through the second lumen, as taught by McPherson in order to facilitate positioning of the piercing tip of the biopsy device 40.
Claim(s) 64, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0088457 (Johnson) in view of U.S. Patent Publication Number 2016/0354056 (Signh et al.), U.S. Patent Publication Number 2018/0065248 (Barrai et al.) as applied to claim 52 above, and further in view of U.S. Patent Publication Number 2010/0222647 (Hashimshony et al.)
Regarding claim 64, Johnson fails to disclose one or more second sensors configured to detect bleeding into the anatomic passageway from outside the anatomic passageway.
Hashimshony et al., from the same field of endeavor teaches a similar medical system as shown in Figures 4-6, which includes a catheter with one or more first sensors mounted on a sensing probe (sensing probe 602, see paragraphs [0094] [0146]); and a processor (processor 688, see paragraph [0146]) capable of detecting bleeding into the anatomic passageway from outside the anatomic passageway using the one or more first sensors. See paragraph [0080] discloses the sensing probe is capable of sending a signal which the processor detects as internal bleeding.
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 system disclosed by Johnson in view of Signh, and Barrai to include the sensing probe and processor disclosed by Hashimshony et al. in the medical system disclosed by Johnson in order to provide a computational means to detect internal bleeding.
Claim(s) 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0088457 (Johnson) in view of U.S. Patent Publication Number 2016/0354056 (Signh et al.), U.S. Patent Publication Number 2018/0065248 (Barrai et al.), U.S. Patent Publication Number 2010/0222647 (Hashimshony et al.) as applied to claim 64 above, and further in view of U.S. Patent Publication Number 2015/0011856 (Arevalos et al.)
Regrading claim 65, Johnson in view of Signh, and Barrai fail to disclose the processor is further configured to perform in response to detecting the bleeding into the anatomic passage way, including an audio alert.
Arevalos et al, from the same field of endeavor teaches a similar medical system as shown in Figure 1, where the system includes a processor configured to perform in response to detecting the bleeding into the anatomic passage way, including an audio alert. See paragraphs [0010], [0044], [0056].
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 medical system disclosed by Johnson in view of Signh, and Barrai such that the processor was configured to perform in response to detecting the bleeding into the anatomic passage way, including an audio alert in order to provide an audio or visual alert when internal bleeding is detected.
Claim(s) 52, 66, 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,728,133 (Kontos.) in view of U.S. Patent Publication Number 2016/0354056 (Signh et al.), U.S. Patent Publication Number 2018/0065248 (Barrai et al.)
Regarding claims 52, 66, 68 Kontos discloses as shown in Figures 2, 8 a medical system capable of performing a minimally invasive procedure within an anatomic passageway, the system comprising: an outer catheter (introducer sheath 60, see col. 5, lines 29-39) comprising one or more first lumens; a sealing device (device 10, has balloon 20 which is discloses as capable of sealing, see col. 4, lines 5-19) coupled to the outer catheter (because it is disposed through it), wherein: the sealing device is a balloon catheter (device is a catheter 14 with a balloon 20 and thus a balloon catheter) to be deployed through the one or more first lumens.
Kontos fails to disclose one or more first sensors.
Signh et al., from the same filed of endeavor teaches a similar medical system as shown in Figures 3-5, 26, where the system one or more first sensors; and a control system capable of detecting one of more anatomical features beyond a surface of an anatomical passage in which at least one of the an outer catheter or inner instrument is positioned, where the one or more anatomical features include at least one target tissue, for the purpose of knowing where an area of the body is the surgeon would like to avoid. See paragraph [0108].
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 system disclosed by system disclosed by Kontos to include the one or more first sensors; and a control system configured to detect one of more anatomical features beyond a surface of an anatomical passage in which at least one of the outer catheter or inner instrument is positioned taught by Signh et al. in order to know where an area of the body is the surgeon would like to avoid.
Barrai et al., from the same field of endeavor teaches a similar system, with a manipulator assembly configured to control movement of at least one of an outer catheter or the inner instrument, and a control system, where the control system capable of controlling the manipulator to disable the advancement of an inner instrument based on one or more fist sensors detecting the one or more anatomical features. See paragraphs [0019], [0021], [0022].
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 system disclosed by Johnson in view of Signh et al. to modify the control system such that it was capable of controlling the manipulator to disable the advancement of the inner instrument based on one or more fist sensors detecting the one or more anatomical features as taught by Barrai et al. in order avoid an area of the body the surgeon does not want the instrument to go.
Claim(s) 69, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0088457 (Johnson) in view of U.S. Patent Publication Number 2016/0354056 (Signh et al.), U.S. Patent Publication Number 2018/0065248 (Barrai et al.) as applied to claim 52 above, and further in view of U.S. Patent Publication Number 2011/0270121 (Johnson et al. ‘121)
Regarding claim 69, Johnson fails to disclose the control system is configured to perform in response to detecting the one or more anatomical features at least one of an audio alert or a visual alert.
Johnson et al. ‘121, from a related field of endeavor teaches a similar control system, where the control system is configured to perform in response to detecting the one or more anatomical features at least one of an audio alert or a visual alert. See claim 7.
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 control system disclosed by Johnson such that it was configured to to perform in response to detecting the one or more anatomical features at least one of an audio alert or a visual alert as taught by Johnson et al. ‘121, in order to alter a user when the system comes close to a part of the anatomy.
Claim(s) 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2018/0065248 (Barrai et al.) in view of U.S. Patent Publication Number 2008/0287963 (Rogers et al.)
Regarding claim 70, Barrai discloses as shown in Figure 1, a method of performing a minimally invasive procedure, the method comprising: detecting, by a control system using one or more sensors (sensors which captured sensor data, see paragraph [0021]), one or more anatomical features beyond a surface of an anatomic passageway in which at least an inner instrument (tool, see paragraph [0022]) is positioned; and controlling, by the control system, a manipulator assembly (robot arm used to control robotically controlled medical instruments, see paragraphs [0019], [0041]) to disable advancement of the inner instrument based on the one or more sensors detecting the one or more anatomical features. See paragraphs [0019], [0021], [0022], [0041].
Barrai fails to disclose an outer catheter and the inner instrument being slidably disposed through the outer catheter.
Rogers et al., from the same field of endeavor teaches a similar method as shown in Figure 1B, where the method includes the step of disposing an inner instrument (one of surgical instruments 101A-101E, see paragraph [0036]) wherein the method includes the step of providing an outer catheter (entry guide 108, see paragraph [0037]) and the inner instrument being slidably disposed through the outer catheter, for the purpose of guiding the inner instrument in the body.
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 method disclosed by Barrai by including outer catheter taught by Rogers et al. in order to guide the inner instrument in the body.
Claim(s) 71, is/are rejected under 35 U.S.C. 103 as being unpatentable over over U.S. Patent Publication Number 2018/0065248 (Barrai et al.) in view of U.S. Patent Publication Number 2008/0287963 (Rogers et al.) as applied to claim 70 above, and further in view of U.S. Patent Publication Number 2011/0270121 (Johnson et al.)
Regarding claim 71, Barrai fails to disclose performing, in response to detecting the one or more anatomical features, at least one of an audio or visual alert.
Johnson et al., from a related field of endeavor teaches a similar method, where the method includes performing, in response to detecting the one or more anatomical features, at least one of an audio or visual alert. See claim 7.
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 method disclosed by Barrai such that it included the step of performing in response to detecting the one or more anatomical features at least one of an audio alert or a visual alert as taught by Johnson et al. in order to alter a user when the system comes close to a part of the anatomy.
Claim(s) 72, is/are rejected under 35 U.S.C. 103 as being unpatentable over over U.S. Patent Publication Number 2018/0065248 (Barrai et al.) in view of U.S. Patent Publication Number 2008/0287963 (Rogers et al.) as applied to claim 70 above, and further in view of U.S. Patent Publication Number 2014/0088457 (Johnson et al.)
Regarding claim 72, Barrai fails to disclose deploying a sealing device coupled to the outer catheter to seal the anatomic passage.
Johnson et al., from a related field of endeavor teaches a similar method, where the method includes the step of deploying a seal device coupled to an outer catheter (catheter, see paragraph [0044]) to seal an anatomical passageway for the purpose of preventing internal bleeding from spreading beyond the outer catheter. See paragraphs [0052], [0053], [0055].
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 method disclosed by Barrai such that it included the step of deploying a sealing device coupled to the outer catheter to seal the anatomic passage in order to prevent internal bleeding from spreading beyond the outer catheter.
Response to Arguments
Applicant’s arguments, filed 08/14/2026, with respect to the rejection of claims under Kostrezewski have been considered but are moot in view of the new grounds of rejection.
The applicant’s remarks regarding the rejection of the claims under Signh have been considered but are not persuasive.
The applicant argues Signh does not teach one or more first sensors capable of detecting one or more anatomical features beyond a surface of an anatomical passage because the sensors are detecting anatomical features beyond a surface of an anatomical passage which is artificially created.
In response, the office respectfully disagrees. The applicant is arguing an intended use. It is unclear to the office what is the structural difference between a sensor capable of detecting an anatomical passage naturally created and one that is artificially created. It is the position of the Office that there is none. The applicant describes one or more first sensors capable of detecting one or more anatomical features beyond a surface of an anatomical passage as optical coherence tomography (OCT) device. See paragraph [0048] of the specification.
Signh discloses the same optical coherence tomography (OCT) device to detect anatomical features. See paragraph [0108]
Function follows structure. Since the structural limitations (i.e. an OCT device) are met by the reference, then it may be reasonably concluded that the functional limitations are also met.
The applicant admits Singh does not characterize its sensors as detecting features in “extra-anatomical passageways” The applicant further does not actually dispute the Office’s position that a passage in the anatomy is an anatomical passageway beyond contrasting it with their own invented term “extra-anatomical path”.
Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. The ordinary and customary meaning of a term may be evidenced by a variety of sources, including the words of the claims themselves, the specification, drawings, and prior art. However, the best source for determining the meaning of a claim term is the specification - the greatest clarity is obtained when the specification serves as a glossary for the claim terms. The presumption that a term is given its ordinary and customary meaning may be rebutted by the applicant by clearly setting forth a different definition of the term in the specification. See In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1028 (Fed. Cir. 1997).
In this case, the applicant’s specification does not define “anatomical path” to exclude a path in the anatomy which is created by artificial means. Accordingly, it remains unclear how interpreting anatomic passageway to be narrower than a passage in the anatomy is its broadest reasonable interpretation. The applicant explicitly excludes limiting interpretations in paragraph [0090] of their own specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/ Primary Examiner, Art Unit 3771
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