DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 § 102
3. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
4. Claims 1-5 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Onik U.S. 2018/0263685 (herein referred to as “Onik ‘685”).
5. Regarding Claim 1, Onik ‘685 teaches a system (Fig. 9, para 0053) for collocating an energy for cell lysis and an infusion of a fluid in a target site including tissue of a subject (para 0066), the system comprising:
(a) an energy probe (Fig. 12A, ref num 20, 25) configured to emit an energy into the tissue of the target site thereby causing cell lysis of said tissue (para 0060,; para 0019, “destroy the cellular membranes”); and
(b) an infusion sheath (Fig. 12A, ref num 23) having a lumen configured to at least partially surround the energy probe (see Fig. 12A, ref num 23 surrounds the probe, ref num 25), wherein the infusion sheath is configured to provide a pathway for the fluid to travel distally within the lumen and exit a distal portion of the infusion sheath (para 0066, “EMB treatment probes 20 may have a hollow interior defined by an inner lumen 10 of sufficient diameter to accommodate a spinal needle 9 of one or more standard gauges to be inserted there through for the injection of adjuvant immunotherapy type drugs into the lesion formed by EMB treatment to enhance the immunologic response of said treatment”; see Fig. 17),
wherein the probe is coaxial with the infusion sheath and shares a longitudinal axis (see Figs. 12A-12D) thereby allowing co-location of the energy from the probe and the infusion of the fluid from the infusion sheath in the target site (see Fig. 17, ref num 2 shows the co-location of the energy and infusion of fluid).
6. Regarding Claim 2, Onik ‘685 teaches the infusion sheath comprises at least one port in the distal portion of the infusion sheath that is in fluid communication with the pathway of the infusion sheath (Fig. 17, ref num 8, para 0066-0067).
7. Regarding Claim 3, Onik ‘685 teaches the at least one port is a slit (Fig. 17, ref num 8).
8. Regarding Claim 4, Onik ‘685 teaches the energy probe and the infusion sheath are translatable relative to one another along the longitudinal axis. (see Fig. 12D; para 0060, “Insulating sheath 23 and outer electrode 24 are preferably movable as a unit along a lateral dimension of core 21 so that the surface area of core 21 that is exposed to the treatment area is adjustable, thus changing the size of the lesion created by the EMB pulses”).
9. Regarding Claim 5, Onik ‘685 fails teaches the pathway and port are configured to deliver the fluid while the probe is within the pathway at the distal end of the infusion sheath (para 0066, “EMB treatment probes 20 may have a hollow interior defined by an inner lumen 10 of sufficient diameter to accommodate a spinal needle 9 of one or more standard gauges to be inserted there through for the injection of adjuvant immunotherapy type drugs into the lesion formed by EMB treatment to enhance the immunologic response of said treatment”; see Figs. 12C and 12D);
10. Regarding Claim 8, Onik ‘685 teaches the fluid is a therapeutic agent effective in treating the tissue at the tissue site (para 0081, “the inner lumen 10 may be sized to allow for the injection of biochemical or biophysical nano-materials there through into the EMB lesion to enhance the efficacy of the local ablative effect, or to allow injection of reparative growth stimulating drugs, chemicals or materials”).
11. Regarding Claim 9, Onik ‘685 teaches the therapeutic agent is a cancer therapeutic agent (para 0017, “It is, therefore, an object of the present invention to provide a method for the treatment of prostate cancer in an outpatient or doctor's office setting via tissue ablation using electrical pulses which causes immediate cell death through the mechanism of complete break down of the membrane of the prostate cancer cell”).
12. Regarding Claim 10, Onik ‘685 teaches the energy induces cryolysis of tissue at the target site (para 0028, “electrodes placed OD the skin of a patient can deliver an RFEMB treatment with preferential cell lysis”).
Claim Rejections - 35 USC § 103
13. 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.
14. Claims 6, 11-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Onik ‘685 and in view of Pearson U.S. 2003/0130711 (herein referred to as “Pearson”).
15. Regarding Claim 6, Onik ‘685 fails to teach a valve configured to eliminate proximal flow of the fluid during and/or following delivery thereof to the target site.
Pearson teaches a valve configured to eliminate proximal flow of the fluid during and/or following delivery thereof to the target site (para 0141, “Use of an indexing valve allows independent control of flow rates through individual lumens 72 in turning allowing for independent control of infusion through electrodes 18. This in turn, allows for greater control of the infusion process including the creation of smaller or larger zones of infusion around individual electrodes 18. Such control is particularly beneficial for bipolar embodiments where, in order to prevent shorting, it is desirable not to have a continuous infusion zone between one or more bipolar electrodes 18 and a return electrode”; understood the valve would eliminate proximal flow). This controls the amount of infusion delivered to the target site (para 0141). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onik ‘685 to have a valve in order to control the amount of infusion delivered to the target site.
16. Regarding Claim 11, Onik ‘685 teaches a method for co-locating energy delivery and fluid delivery to tissue at a target site in a patient (Figs. 9, 12A-12D; para 0053, 0066-0067), the method comprising:
a. disposing a cryolysis system comprising an energy probe coaxial with and positioned within a lumen of an infusion sheath at least partially into a patient such that a distal end of the energy probe is disposed in the target site (Fig. 9, 11, 12A-12D, ref num 20, 25, 23; para 0060);
b. providing energy from the energy probe to the tissue thereby lysing at least a portion of a plurality of cells in the target site (para 0017);
c. slidably moving the infusion sheath in a distal direction along a longitudinal axis of the energy probe from a first position to a second position, wherein the second position is spaced apart from the first position (see Figs. 12C and 12D);
d. delivering an infusion of a fluid to the target site through the infusion sheath (para 0066, “EMB treatment probes 20 may have a hollow interior defined by an inner lumen 10 of sufficient diameter to accommodate a spinal needle 9 of one or more standard gauges to be inserted there through for the injection of adjuvant immunotherapy type drugs into the lesion formed by EMB treatment to enhance the immunologic response of said treatment”; see Fig. 17); and
Onik ‘685 fails to teach removing the infusion sheath and the energy probe from the target site.
Pearson teaches a method of analogous art (abstract, para 0073), wherein the method comprising removing an infusion sheath (para 0138; Fig. 23a/b and 2) and energy probe (Fig. 2, ref num 18) from the target site (para 0160). This is a common practice when completing the treatment method (para 0160). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onik ‘685 to remove the infusion sheath and energy probe from the target site upon completion of the treatment in order to ensure there is no unnecessary damage to the surrounding tissue.
17. Regarding Claim 12, Onik ‘685 teaches delivering the fluid out one or more openings in the distal end of the infusion sheath, wherein such openings are disposed radially through a wall of the infusion sheath to be in fluid communication with a fluid pathway within a lumen of the infusion sheath that extends to a proximal end of the cryolysis system to a fluid source (Fig. 17, ref num 8, para 0066-0067).
18. Regarding Claim 13, Onik ‘685 teaches the one or more openings is a slit (Fig. 17, ref num 8).
19. Regarding Claim 14, Onik ‘685 teaches delivering the fluid and slidably moving the infusion sheath are done concurrently (para 0066, “can be used for such purposes before, during or after the application of EMB pulses from the EMB treatment probe 20”; para 0060, “Insulating sheath 23 and outer electrode 24 are preferably movable as a unit along a lateral dimension of core 21 so that the surface area of core 21 that is exposed to the treatment area is adjustable, thus changing the size of the lesion created by the EMB pulses”).
20. Regarding Claim 15, Onik ‘685 teaches slidably moving the infusion sheath in a proximal direction along the longitudinal axis of the energy probe from the second toward the first position (see Figs. 12C and 12D), wherein delivering the fluid and slidably moving in this proximal direction are done concurrently (para 0066, “can be used for such purposes before, during or after the application of EMB pulses from the EMB treatment probe 20”; para 0060, “Insulating sheath 23 and outer electrode 24 are preferably movable as a unit along a lateral dimension of core 21 so that the surface area of core 21 that is exposed to the treatment area is adjustable, thus changing the size of the lesion created by the EMB pulses”; it is understood that adjusting the treatment area via sliding the infusion sheath may be done during the delivery of the fluid).
21. Regarding Claim 20, Onik ‘685 fails to teach a distal end of the infusion sheath is located at a location distal to the distal end of the energy probe when in the second position. However, since Onik ‘685 teaches movement of the infusion sheath to adjust the size of the treatment site (para 0060, 0066), then it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the distal end of the infusion sheath located distal to the distal end of the energy prober, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
22. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Onik ‘685 and in view of Onik U.S. 2018/0028260 (herein referred to as “Onik ‘260”).
23. Regarding Claim 7, Onik ‘685 fails to teach a tube in fluid communication with the pathway of the infusion sheath at a distal end of the tube and in fluid communication with a source of the fluid at a proximal end of the tube.
Onik ‘260 teaches a system of analogous art (Figs. 9 and 14), wherein the system comprises a tube in fluid communication with the pathway of the infusion sheath at a distal end of the tube and in fluid communication with a source of the fluid at a proximal end of the tube (Fig. 14, see tube connected to “reservoir”).This provides the infusion to the device (para 0102). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onik ‘685 to have a fluid source in communication with the distal end of the tube to provide the infusion to the target site.
Allowable Subject Matter
24. Claims 16-19 contain allowable material. The prior art of record fails to specifically teach slidably moving the infusion sheath distal to the second position to a third position, wherein when in such third position buckling of the infusion sheath is reduced relative to when in the first or second positions and/or mechanical strength of the system at the location of the energy probe is enhanced relative to the energy probe alone without the sheath distal advancement, wherein the enhanced mechanical strength is provided about the distal end of the energy probe upon disposing the cryolysis system in the patient. The prior art also fails to provide sufficient motivation to make such specific modifications and would require improper use of hindsight to arrive at the claimed invention when considered along or in any proper combination.
25. Claims 16-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
26. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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