DETAILED ACTION
Applicant’s preliminary amendment, filed May 14, 2024, is fully acknowledged by the Examiner. Currently, claims 18-37 are pending and newly added with claims 1-17 cancelled. The following is a complete response to the May 14, 2024 communication.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 25, the claim recites the limitation of “the shaft of the endoscope” in line 6 of the claim. Both the recitations of “the shaft” and “the endoscope” fail to have proper antecedent basis for in the claim. This lack of antecedent basis further renders the scope of the claim as indefinite because it is unclear to which structure the collar adapter is attached to when the claim does not provide proper basis for “the shaft of the endoscope”. For the purpose of examination, the Examiner will be interpreting the collar adapter as being capable of attaching to a shaft of an endoscope. Claims 26-32 are rejected for their respective dependency on claim 25. Appropriate correction is required.
Regarding claim 30, the claim further recites additional limitations with respect to the shaft of the endoscope noted in the rejection of claim 25 under 35 U.S.C. 112(b) above. The Examiner is, therefore, of the position that the scope of claim 30 is further indefinite given that “the shaft of the endoscope” has not been properly established in the claim. The Examiner will be interpreting the at-issue limitations for the purpose of examination that the collar adapter only need be functionally capable of providing of the sliding attachment set forth in claim 30. Appropriate correction is required.
Regarding claim 33, the claim recites the limitation of “the shaft of the endoscope” in line 6 of the claim. Both the recitations of “the shaft” and “the endoscope” fail to have proper antecedent basis for in the claim. This lack of antecedent basis further renders the scope of the claim as indefinite because it is unclear to which structure the collar adapter is attached to when the claim does not provide proper basis for “the shaft of the endoscope”. For the purpose of examination, the Examiner will be interpreting the collar adapter as being capable of attaching to a shaft of an endoscope. Claims 34-37 are rejected for their respective dependency on claim 33. Appropriate correction is required.
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 18 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) and further in view of Friedman et al. (US Pat. No. 9,144,431 B2) and Grossman (US Pat. Pub. 2006/0189972 A1).
Regarding claim 18, Nishina provides for an endoscopic or endobronchial tumor treatment system (see figures 39, 40 and 55) comprising:
an ultrasound probe (EUS 2A1) comprising a shaft (insertion portion 21) and an ultrasonic transducer attached to a distal end of the shaft (30A), the shaft defining a working channel (a channel defined at 32),
a sheath defining a first lumen (sheath 53 defines a first lumen therethrough), the sheath being slidably disposable within the working channel and extendable from a distal end of the working channel (see at least [0102] providing for 53 to be insertable within the working channel and to extend from the opening at 32),
a needle slidably disposed within the first lumen, the needle defining a lumen (54), and
an electrode lead slidably disposed within a second lumen and configured to be an anode (see figure 55 with 3 extending from a second lumen 32a of the device).
While Nishina contemplates the limitations above and further provides for the inclusion of multiple lumens as well as multiple treatment devices, Nishina fails to specifically contemplate for the sheath to specifically define the second lumen or for the needle within the first lumen to be configured to be a cathode.
Friedman discloses an exemplary treatment device for use with an endoscopic system and specifically provides for a sheath that includes a first lumen and a second lumen (see figure 2B with the sheath at 110a with the lumens at 112a and 114a). Therefore, it is the Examiner’s position that it would have been obvious to utilize a sheath with a first and second lumen through the working channel 32 of Nishina to provide for an alternative manner of delivering both the needle and electrode lead to the target location within the body. Nishina readily contemplates the usage of various numbers of working channels as well as various iterations of the number and types of probes used. As such, the Examiner finds that the use of a single working channel with a dual-lumen sheath would have been an obvious consideration in light of the teaching of Friedman that would function equally as well and with a reasonable expectation of success to provide endoscopic delivery of the needle and electrode lead to the target location within the body.
Friedman fails to cure the deficiency in Nishina for the needle to be configured to function as a cathode. Grossman, however, provides for the use of a endoscopically placed needle as an electrode for delivering energy to another portion of the device (at least 32 in figure 2B is described as a needle capable of delivering RF energy). Thus, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the needle of Nishina as an electrode per the teaching of Grossman. Such provides the user the ability to select a desired treatment location/area for applying energy by the device. Nishina itself contemplates utilizing two or more electrode leads itself, and the use of the needle as an electrode would result in both the ability to deliver fluid and markers to the location of treatment while also allowing for the delivery of energy.
Regarding claim 21, Nishina provides that the needle is configured to obtain a tumor tissue sample and to inject processed tissue or other immune enhancing substances into a tumor (the needle 5 has a passageway therethrough thereby providing for the functional capability set forth in claim 21).
Regarding claim 22, Nishina provides that the sheath is distally extendable from a distal end of the working channel (see at least [0102] providing for 53 to be insertable within the working channel and to extend from the opening at 32).
Regarding claim 23, in view of the combination in the rejection of claim 18 above, the combined needle capable of functioning as a cathode would further be configured to deliver a pulsed electrical field or electroporation energy to a target tissue. Such is a functional recitation of the intended use of the needle that would fail to structurally define the claimed needle from that of the prior art.
Regarding claim 24, Nishina provides that the ultrasound probe is configured to provide ultrasonic visualization for endoscopically or endobronchially treating tumors (the probe 2A1 is capable of providing such visualization via 3A functioning to provide for endoscopic imaging).
Claims 25, 26 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) and further in view of Grossman (US Pat. Pub. 2006/0189972 A1).
Regarding claim 25, Nishina provides for an endoscopic or endobronchial tumor treatment system (See figures 39, 40 and 55) comprising:
an ultrasound probe (probe at 2) comprising a shaft (insertion portion at 21) and an ultrasonic transducer attached to a distal end of the shaft (transducer at 30/30A), the shaft defining a working channel (the passageway through 21 operably coupled to the opening at 32),
a needle slidably disposed within the working channel, the needle defining a lumen (see figure 55 with the needle at 5A),
a collar adapter configured to attach to a shaft of an endoscope and defining a lumen (the collar formed at the distal end of 21a1 as in figure 55; such defines a lumen at 32a), and
an electrode lead comprising one or more contact electrodes and being slidably disposed within the lumen of the collar adapter and configured to be an anode (ablation device 3 as in figure 55; 3 is slidably disposed within the lumen at 32a and through the remainder of the device).
While Nishina contemplates the limitations above, Nishina fails to specifically contemplate for the needle to be configured to be a cathode. Grossman, however, provides for the use of a endoscopically placed needle as an electrode for delivering energy to another portion of the device (at least 32 in figure 2B is described as a needle capable of delivering RF energy). Thus, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the needle of Nishina as an electrode per the teaching of Grossman. Such provides the user the ability to select a desired treatment location/area for applying energy by the device. Nishina itself contemplates utilizing two or more electrode leads itself, and the use of the needle as an electrode would result in both the ability to deliver fluid and markers to the location of treatment while also allowing for the delivery of energy.
Regarding claim 26, in view of the combination with Grossman above, the combined needle provide for an outer insulative covering on the needle except for the distal end portion of the needle (see figures 2A/B with the insulation at 34 and the exposed tip at 32).
Regarding claim 29, Nishina provides that the needle is configured to obtain a tumor tissue sample and to inject processed tissue or other immune enhancing substances into a tumor (the needle 5 has a passageway therethrough thereby providing for the functional capability set forth in claim 25).
Regarding claim 30, Nishina further provides that the collar adapter is capable of being slidably attached to an outer diameter of the shaft of the endoscope (the collar formed at the distal end of 21a1 as in figure 55 would be capable of being attached to an outer diameter of an endoscope shaft).
Regarding claim 31, in view of the combination in the rejection of claim 25, the combined system would provide that each of the electrode lead and the needle are positioned to contact tissue when configured in a deployed state (via each of 3 and 5A functioning to contact tissue in a deployed state).
Regarding claim 32, in view of the combination in the rejection of claim 25 above, the combined needle capable of functioning as a cathode would further be configured to deliver a pulsed electrical field or electroporation energy to a target tissue. Such is a functional recitation of the intended use of the needle that would fail to structurally define the claimed needle from that of the prior art.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) in view of Friedman et al. (US Pat. No. 9,144,431 B2) and Grossman (US Pat. Pub. 2006/0189972 A1) as applied to claim 18 above, and further in view of Cosman (US Pat. Pub. 2017/0050041 A1).
Regarding claim 19, the combination in the rejection of claim 18 fails to provide that the electrode lead is a stylet-driven flexible lead that is configurable by an internal stylet. Cosman discloses a similar manner of directing a flexible electrode lead within the body (see figures 4A and 4B with the lead shown therein) wherein the lead is a stylet-driven flexible lead (via such being driven by the stylet 460) so as to be configurable by an internal stylet (with 460 functioning as in [0152]-[0159] to function to, for example, aid in the flexibility of the tip of the electrode lead). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a flexible, style-driven electrode lead with an internal stylet as in Cosman to the electrode lead of Nishina to provide for an exemplary member of controlling the desired flexibility of the tip of the electrode lead. Such would allow for, as set forth in [0155] of Cosman to aid in the “maneuvering of the electrode in the human body” especially when directing the electrode lead to a desired location of treatment.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) in view of Grossman (US Pat. Pub. 2006/0189972 A1) as applied to claim 18 above, and further in view of Cosman (US Pat. Pub. 2017/0050041 A1).
Regarding claim 27, the combination in the rejection of claim 25 fails to provide that the electrode lead is a stylet-driven flexible lead that is configurable by an internal stylet. Cosman discloses a similar manner of directing a flexible electrode lead within the body (see figures 4A and 4B with the lead shown therein) wherein the lead is a stylet-driven flexible lead (via such being driven by the stylet 460) so as to be configurable by an internal stylet (with 460 functioning as in [0152]-[0159] to function to, for example, aid in the flexibility of the tip of the electrode lead). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a flexible, style-driven electrode lead with an internal stylet as in Cosman to the electrode lead of Nishina to provide for an exemplary member of controlling the desired flexibility of the tip of the electrode lead. Such would allow for, as set forth in [0155] of Cosman to aid in the “maneuvering of the electrode in the human body” especially when directing the electrode lead to a desired location of treatment.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) in view of Friedman et al. (US Pat. No. 9,144,431 B2) and Grossman (US Pat. Pub. 2006/0189972 A1) as applied to claim 18 above, and further in view of Machell (US Pat. Pub. 2008/0033426 A1).
Regarding claim 20, while Nishina provides that the electrode lead includes two contact electrodes (see [0100] with the electrodes 43A and 43B) fails to specifically recite that the electrode lead includes three or more contact electrodes. Machell provides for a similar flexible electrode lead as that of Nishina and specifically contemplates the inclusion of three or more contact electrodes (see figure 2 with electrodes 20/22/24/26). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized three or more contact electrodes as in Machell to the electrode lead of Nishina to provide for an alternative manner of providing bipolar treatment to a target location. Machell specifically provides that three or more electrode contacts provides the user the ability to select desired combinations of electrode contacts to achieve treatment of a desired area and/or volume of tissue along the electrode lead without needing to move/manipulate the electrode lead (See at least [0048] and [0060]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) in view of Grossman (US Pat. Pub. 2006/0189972 A1) as applied to claim 18 above, and further in view of Machell (US Pat. Pub. 2008/0033426 A1).
Regarding claim 28, while Nishina provides that the electrode lead includes two contact electrodes (see [0100] with the electrodes 43A and 43B) fails to specifically recite that the electrode lead includes three or more contact electrodes. Machell provides for a similar flexible electrode lead as that of Nishina and specifically contemplates the inclusion of three or more contact electrodes (see figure 2 with electrodes 20/22/24/26). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized three or more contact electrodes as in Machell to the electrode lead of Nishina to provide for an alternative manner of providing bipolar treatment to a target location. Machell specifically provides that three or more electrode contacts provides the user the ability to select desired combinations of electrode contacts to achieve treatment of a desired area and/or volume of tissue along the electrode lead without needing to move/manipulate the electrode lead (See at least [0048] and [0060]).
Claims 33, 34 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (US Pat. Pub. 2011/0098704 A1), and further in view of Nishina et al. (US Pat. Pub. 2012/0078094 A1).
Regarding claim 33, Long provides for an endoscopic or endobronchial tumor treatment system (see figures 1 and 4A-B) comprising,
an imaging probe comprising a shaft (endoscope 12 having a shaft 32) and an imaging modality attached to a distal end of the shaft (see [0029] providing for the imaging via the distal end of the endoscope 12)
the shaft defining a working channel; a needle slidably disposed within the working channel, the needle defining a lumen and configured to be a cathode;
a collar adapter capable of being attached to a shaft of an endoscope (33 is capable of contacting an endoscope so as to be attached thereto) defining a first lumen, a second lumen, and a third lumen (see figures 2A-2D and 4A-4B where the embodiment in figures 4A and B with 33 having three lumens therein; see also [0049] and [0050]),
a first electrode lead slidably disposed within the first lumen of the collar adapter and configured to be an anode (124),
a second electrode lead slidably disposed within the second lumen of the collar adapter and configured to be an anode (125), and
a third electrode lead slidably disposed within the third lumen of the collar adapter and configured to be an anode (126).
Long fails to provide that the imaging probe is an ultrasound probe having an ultrasound transducer disposed at the distal end, and for a needle slidably disposed within the working channel, the needle defining a lumen and configured to be a cathode. Nishina provides for an exemplary imaging probe similar to that of Long and specifically provides that such is an ultrasound endoscope (see figures 2 and 9 with the endoscope 2 with the transducer 30). Nishina further provides for the inclusion of a needle slidably disposed within the working channel (see figures 2 and 9 with the probe 3 slidably disposed within the channel 32), the needle defining a lumen and configured to be a cathode (via 42 of 3 being a tube and configured to connect to a cathode of an electrical source).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the ultrasound endoscope as in figures 2/9 of Nishina in place of the endoscope of that of Long to provide for an alternative manner of imaging and directing energy to tissue within the body. Nishina, like Long, contemplates the usage of an ultrasound endoscope with multiple electrodes (see figures 41A-42 providing for Nishina to utilize three electrode like that in Long), and would further provide the ability of the ultrasound endoscope to provide both visual imaging as well as ultrasound imaging to provide for targeting of desired tissue within the body.
Regarding claim 34, the combination of Long and Nishina provides for an outer insulative covering on the needle except for on a distal end portion of the needle (see [0098] of Nishina providing that the needle would include an insulating portion at 42 with an exposed portion at 43).
Regarding claim 37, in view of the combination in the rejection of claim 33 above with the needle provided per Nishina, the combined system would include the needle to be configured to obtain a tumor tissue sample and to inject processed tissue or other immune enhancing substances into a tumor (the needle 5 has a passageway therethrough thereby providing for the functional capability set forth in claim 21).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (US Pat. Pub. 2011/0098704 A1) further in view of Nishina et al. (US Pat. Pub. 2012/0078094 A1) as applied to claim 33 above and further in view of Cosman (US Pat. Pub. 2017/0050041 A1).
Regarding claim 35, while Long provides for the first, second, and third electrode leads, Long fails to provide that each electrode lead is a stylet-driven flexible lead that is configurable by a respective internal stylet. Cosman discloses a similar manner of directing a flexible electrode lead within the body (see figures 4A and 4B with the lead shown therein) wherein the lead is a stylet-driven flexible lead (via such being driven by the stylet 460) so as to be configurable by an internal stylet (with 460 functioning as in [0152]-[0159] to function to, for example, aid in the flexibility of the tip of the electrode lead). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a flexible, style-driven electrode lead with an internal stylet as in Cosman to each of the electrode leads of Long to provide for an exemplary manner of controlling the desired flexibility of the tip of each of the first, second and third electrode leads. Such would allow for, as set forth in [0155] of Cosman to aid in the “maneuvering of the electrode in the human body” especially when directing the electrode lead to a desired location of treatment.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (US Pat. Pub. 2011/0098704 A1) further in view of Nishina et al. (US Pat. Pub. 2012/0078094 A1) as applied to claim 33 above and further in view of Machell (US Pat. Pub. 2008/0033426 A1).
Regarding claim 36, Long fails to provide that the first, second, and third electrode leads each comprise three or more contact electrodes. Machell provides for a similar flexible electrode lead as that of Long and specifically contemplates the inclusion of three or more contact electrodes (see figure 2 with electrodes 20/22/24/26). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized three or more contact electrodes as in Machell to each electrode lead of Long to provide for an alternative manner of providing bipolar treatment to a target location. Machell specifically provides that three or more electrode contacts provides the user the ability to select desired combinations of electrode contacts to achieve treatment of a desired area and/or volume of tissue along the electrode lead without needing to move/manipulate the electrode lead (See at least [0048] and [0060]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794