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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/5/2026 was filed after the mailing date of the Non-Final Office Action on 2/3/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The Amendment filed 5/4/2026 has been entered. Claims 2-22 remain pending in the application.
Claim Objections
Claims 13 and 21-22 are objected to because of the following informalities:
Claim 13 recites the limitation “the pancreatic magnum artery” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation “the isolation lengths” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 22, line 1, the recitation “second occluder” appears to be amended to recite “the second occluder” to refer to “a second occluder” recited in claim 2, line 7.
Regarding claim 22, line 2, the recitation “occulder” appears to be amended to recite “occluder”.
Appropriate correction is required.
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.
Claim 22 is 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 22, the recitation “wherein the first occluder and second occluder are of a same size … is larger than the second occluder” renders the claim indefinite because the claim is unclear regarding how the apparatus can have all three different scenarios at the same time i.e. to have same size and different sizes of the first and second occluders. For examination purposes, examiner construes that first and second occluders meet one of the listed different respective sizes in claim 22.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2, 4-6, 11 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison et al. (US 2005/0059931 A1) in view of Andreas et al. (US 2005/0149159 A1) and further in view of Looper et al. (US 2013/0281971 A1).
Regarding claim 2, Garrison discloses an apparatus (figure 1A), comprising:
an inner catheter 2 defining an inner catheter lumen 17 (figures 3, 4, 7) configured to receive a guidewire (paragraph 0045, lines 8-11);
an outer catheter 4 defining a first lumen 20 (figure 5, paragraph 0049, lines 2-5) configured to introduce a therapeutic material to one or more target vessels, and a second lumen 13 (paragraph 0047) configured to slidably receive at least a portion of the inner catheter;
a first occluder 3 coupled to the inner catheter 2;
a second occluder 5 coupled to the outer catheter 4, the second occluder 5 disposed proximal to the first occluder 3, a distance between the first occluder and the second occluder being adjustable (paragraph 0006, lines 11-15);
a pressure transducer (paragraph 0045, lines 11-15) configured to detect a pressure within the target vessel between the first occluder 3 and the second occluder 5 and configured to guide delivery of the therapeutic material to the one or more target vessels (paragraph 0019, lines 2-13, “configured to guide delivery” is pretty broad term and would also mean to recite rate of delivery to prevent exceeding maximum pressure as explained by Garrison) but is silent regarding a handle, configured to allow for single handed operation of the apparatus, the handle comprising an actuator on the handle that includes a set of protrusions that are configured to be sequentially engaged as the actuator is moved between a plurality of predetermined settings corresponding to predetermined distances between an end portion of the outer catheter and an end portion of the inner catheter, further wherein the handle comprises a visual indicator of the predetermined settings indicating a position of the actuator and configured to determine a desired distance to move the actuator.
However, Andreas teaches a design of devices and methods for controlling and indicating the length of an interventional element comprising a handle 28 (figure 2A, examiner construes element 56 being part of element 28), configured to allow for single handed operation of the apparatus (element 28 would allow single handed operation), the handle 28 comprising an actuator 58 on the handle that includes a set of markings 60 that are configured to be sequentially engaged as the actuator is moved between a plurality of predetermined settings (paragraph 0063, paragraph 0065, lines 32-35) corresponding to predetermined distances between an end portion of the outer catheter 38 and an end portion of the inner catheter 36, further wherein the handle 28 comprises a visual indicator 60 (paragraph 0073, lines 11-13) of the predetermined settings indicating a position of the actuator and configured to determine a desired distance to move the actuator for the purpose of having improved ways of controlling and providing indication of balloon length (paragraph 0010).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the apparatus of Garrison to incorporate a handle, configured to allow for single handed operation of the apparatus, the handle comprising an actuator on the handle that includes a set of protrusions that are configured to be sequentially engaged as the actuator is moved between a plurality of predetermined settings corresponding to predetermined distances between an end portion of the outer catheter and an end portion of the inner catheter, further wherein the handle comprises a visual indicator of the predetermined settings indicating a position of the actuator as taught by Andreas for the purpose of having improved ways of controlling and providing indication of balloon length (paragraph 0010).
While Andreas discloses the visual indicator 60 could include alphanumeric symbols or other appropriate indicators (paragraph 0063, lines 2-5), Garrison modified in view of Andreas is silent regarding a set of protrusions and wherein the visual indicator corresponds with the protrusions associated with the plurality of predetermined settings.
However, Looper teaches a design of a catheter allowing variable dosing including a set of markings and visual indicator 21 (figure 1) comprising a set of protrusions (paragraph 0017, lines 1-4) and wherein the visual indicator (examiner construes that “visual indicator” corresponds to the numbers associated with the lines and protrusions refers to lines in graduated marking) corresponds with the protrusions associated with the plurality of predetermined settings for the purpose of using a well-known approaches in placing the protrusions and visual markers on medical device (paragraph 0017, figure 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the set of markings and visual indicator of Garrison in view of Andreas to incorporate a set of protrusions and wherein the visual indicator corresponds with the protrusions associated with the plurality of predetermined settings as taught by Looper for the purpose of using a well-known approach in placing the protrusions and visual markers on medical device (paragraph 0017, figure 1).
Garrison in view of Andreas is silent regarding wherein the desired distance corresponds to a distance of a target vessel configured to individualize delivery of the therapeutic materials to anatomy of a patient.
However, Garrison focuses on varying the space between the balloons (paragraph 0043) to provide localized delivery in the desired isolated space (paragraph 0007). Andreas discloses the use of actuator to vary the distance between the between an end portion of the outer catheter and an end portion of the inner catheter. Additionally, the limitation wherein the desired distance corresponds to a distance of a target vessel configured to individualize delivery of the therapeutic materials to an anatomy of a patient. Therefore, Garrison modified in view of Andreas would result in a modified device which is capable to determine a desired distance wherein the desired distance corresponds to a distance of a target vessel configured to individualize delivery of the therapeutic materials to an anatomy of a patient.
Regarding claim 4, Garrison discloses wherein the first occluder 3 includes one of an expandable filter and an inflatable balloon (figure 1A).
Regarding claim 5, Garrison discloses wherein the first occluder 3 and the second occluder 5 define an isolated region of the target vessel, the first lumen 20 of the outer catheter is configured to allow atraumatic introduction of therapeutic cells into the isolated region (element 20 is configured to perform the claimed function).
Regarding claim 6, Garrison discloses wherein the first lumen 20 of the outer catheter 4 is configured to allow rapid infusion of the therapeutic material (element 20 is configured to perform the claimed function).
Regarding claim 11, Garrison discloses the distance between the first occluder and the second occluder is adjustable (paragraph 0065, lines 5-8). However, Garrison does not explicitly disclose the distance between the first occluder and the second occluder is adjustable between 3 cm and 15 cm.
There is no evidence of record that establishes that changing the distance would result in a difference in a function of Garrison. Further, a person having ordinary skill in the art, being faced with modifying the distance between the first occluder and the second occluder would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended being given the claimed distance range. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be within the claimed range, and offering other ranges (3 cm to 22 cm, paragraph 0073) and therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distance of Garrison to have the distance between 3 cm and 15 cm as an obvious matter of design choice within the skill of the art.
Regarding claim 21, Garrison discloses wherein the isolation lengths are set for predetermined volumes (paragraph 0007, the isolated space could be created to deliver predetermined volumes).
Regarding claim 22, Garrison wherein the first occluder 3 and second occluder 5 (elements 3 and 5 would meet one of the criteria where elements 3 and 5 are of same size or element 3 is larger or smaller than element 5) are of a same size, wherein the first occluder is smaller than the second occluder, wherein the first occluder is larger than the second occluder.
Claims 3, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison et al. (US 2005/0059931 A1) in view of Andreas et al. (US 2005/0149159 A1) in view of Looper et al. (US 2013/0281971 A1) and further in view of Slater et al. (US 2006/0149218 A1).
Regarding claim 3, Garrison/Andreas/Looper (hereinafter referred as “modified Garrison”) discloses the claimed invention substantially as claimed, as set forth above in claim 2. Garrison is silent regarding further comprising a seal coupled to the outer catheter and configured to prevent therapeutic material from entering the second lumen of the outer catheter.
However, Slater teaches a design (figure 34) of treating the interior of a blood vessel comprising a seal 1104 (figure 34) coupled to the outer catheter 1100 and configured to prevent therapeutic material (material infused into element 1100) from entering the second lumen of the outer catheter for the purpose of preventing the flow of the fluid out from the distal end of the second lumen (figure 34, paragraph 0152, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the apparatus of Garrison to incorporate further comprising a seal coupled to the outer catheter and configured to prevent therapeutic material from entering the second lumen of the outer catheter as taught by Slater for the purpose of preventing the flow of the fluid out from the distal end of the second lumen (figure 34, paragraph 0152, lines 1-4).
Regarding claim 7, modified Garrison discloses the claimed invention substantially as claimed, as set forth above in claim 2. Garrison discloses the distance between the second occluder and the first occluder being adjustable (paragraph 0006, lines 11-15). Furthermore, Garrison modified in view of Slater as explained in the rejection of claim 3 above would result in placing the seal of Slater at the distal end of the outer catheter. Therefore, the modified device of Garrison in view of Slater will result in having the distance between the first occluder and the seal can be adjusted.
Regarding claim 8, modified Garrison discloses the claimed invention substantially as claimed, as set forth above in claim 2. Garrison further discloses wherein the second occlude and the seal collectively have a diameter between 2mm and 12mm (paragraph 0140, the seal of Slater when incorporated into the diameter as explained in the rejection of claim 3 above would not really contribute too much into diameter of the catheter or the balloon due to the design and placement of the seal).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison et al. (US 2005/0059931 A1) in view of Andreas et al. (US 2005/0149159 A1) in view of Looper et al. (US 2013/0281971 A1) and further in view of Hiblar et al. (US 2002/0072706 A1).
Regarding claim 9, modified Garrison discloses the claimed invention as claimed as set above in claim 1 above. Garrison further discloses further comprising the therapeutic material (paragraph 0038, lines 17-24, “cells”). However, modified Garrison is silent regarding wherein the therapeutic material includes stem cells.
However, Hiblar teaches a design of a drug delivery catheter (figure 1) wherein the therapeutic material includes stem cells (paragraph 0043) for the purpose of treating the medical condition/disorder requiring the delivery of the stem cells (paragraphs 0040, 0043).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the therapeutic material of modified Garrison to incorporate wherein the therapeutic material includes stem cells as taught by Hiblar for the purpose of treating the medical condition/disorder requiring the delivery of the stem cells (paragraphs 0040, 0043).
Claim(s) 10, 12, 13, 14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison et al. (US 2005/0059931 A1) in view of Andreas et al. (US 2005/0149159 A1) in view of Looper et al. (US 2013/0281971 A1) and further in view of Zadno-Azizi et al. (US 2002/0016565).
Regarding claim 10, modified Garrison discloses the claimed invention substantially as claimed, as set forth above in claim 2. Garrison further discloses further comprising an adapter (see “A” in fig. 2A below), the adapter including a first port (see “FP” in figure 2A below) and a second port (see “SP” in figure 2A below) but is silent regarding the first port in fluid communication with the first lumen through which the therapeutic agent can be conveyed to a region of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen.
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However, Zadno-Azizi teaches a design of a catheter (figure 3) comprising an adapter 112 having the first port 120 and the second port 123, the first port in fluid communication with the lumen 130 through which the therapeutic agent can be conveyed to a region of the vessel (paragraph 0068, lines 14-17) and the second port 123 in fluid communication with the lumen 130 for the purpose of using the ports to introduce therapeutic agents into the patient’s body and the medical device (paragraph 0068, lines 2-17).
Examiner further construes that even though Zadno-Azizi discloses the use of different port to access same lumen 130, Garrison discloses different lumen and ports. Therefore, one of ordinary skill in the art, modifying the device of Garrison in view of Zadno-Azizi would result in having the first port in fluid communication with the first lumen through which the therapeutic agent can be conveyed to a region of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to define the function of the ports of the device of Garrison to incorporate the first port in fluid communication with the first lumen through which the therapeutic agent can be conveyed to a region of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen as taught by Zadno-Azizi for the purpose of using the ports to introduce therapeutic agents into the patient’s body and the medical device (paragraph 0068, lines 2-17).
Regarding claim 12, Garrison discloses an apparatus (figure 1A) comprising:
an inner catheter 2 defining an inner catheter lumen 17 (figures 3, 4, 7) configured to receive a guidewire (paragraph 0045, lines 8-11);
a first occluder 3 coupled to the inner catheter 2 at a first axial location (location where element 3 is positioned with respect to element 2) along the inner catheter 2;
an outer catheter 4 including a side wall (wall of element 19A forming element 20 in figure 5) defining an infusion aperture (an aperture in element 20 that delivers the fluid, furthermore, claim recites the term “defining” which do not necessarily mean to have an infusion aperture located on sidewall only, instead examiner construes the term “defining” as being able to define at least a portion of an aperture. In Garrison, sidewall of element 20 is at least partially defining the opening through which fluid gets delivered), the outer catheter 4 defining a first lumen 20 in fluid communication with the infusion aperture (opening in element 20 delivering the fluid to the patient) and a second lumen 13 (paragraph 0047), at least a portion of the inner catheter 2 being slidably disposed within the second lumen 13;
a second occluder 5 coupled to the outer catheter 4 at a second axial location (location of element 5 with respect to element 4) along the catheter device (figure 1A), the second axial location spaced apart from the first axial location (figure 1A) such that the infusion aperture is between the first occluder and the second occlude (paragraph 0013, lines 7-10, the opening in element 20 has to be located between elements 3 and 5 in order to deliver the fluid to an isolated segment of the vessel), the first occluder and the second occluder being configured to isolate a segment of a vessel (paragraph 0013, lines 7-10);
an adapter (see “A” in fig. 2A above) coupled to the outer catheter 4, the adapter including a first port (see “FP” in figure 2A above) and a second port (see “SP” in figure 2A above) but is silent regarding the first port in fluid communication with the first lumen through which a therapeutic agent can be conveyed to the segment of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen.
However, Zadno-Azizi teaches a design of a catheter (figure 3) comprising an adapter 112 having the first port 120 and the second port 123, the first port in fluid communication with the lumen 130 through which a therapeutic agent can be conveyed to a segment of the vessel (paragraph 0068, lines 14-17) and the second port 123 in fluid communication with the lumen 130 for the purpose of using the ports to introduce therapeutic agents into the patient’s body and the medical device (paragraph 0068, lines 2-17).
Examiner further construes that even though Zadno-Azizi discloses the use of different port to access same lumen 130, Garrison discloses different lumen and ports. Therefore, one of ordinary skill in the art, modifying the device of Garrison in view of Zadno-Azizi would result in having the first port in fluid communication with the first lumen through which a therapeutic agent can be conveyed to a region of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to define the function of the ports of the device of Garrison to incorporate the first port in fluid communication with the first lumen through which a therapeutic agent can be conveyed to a region of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen as taught by Zadno-Azizi for the purpose of using the ports to introduce therapeutic agents into the patient’s body and the medical device (paragraph 0068, lines 2-17).
Garrison is silent regarding a handle, configured to allow for single handed operation of the apparatus, the handle comprising an actuator on the handle that includes a set of protrusions that are configured to be sequentially engaged as the actuator is moved between a plurality of predetermined settings corresponding to predetermined distances between an end portion of the outer catheter and an end portion of the inner catheter, further wherein the handle comprises a visual indicator of the predetermined settings indicating a position of the actuator and configured to determine a desired distance to move the actuator.
However, Andreas teaches a design of devices and methods for controlling and indicating the length of an interventional element comprising a handle 28 (figure 2A, examiner construes element 56 being part of element 28), configured to allow for single handed operation of the apparatus (element 28 would allow single handed operation), the handle 28 comprising an actuator 58 on the handle that includes a set of markings 60 that are configured to be sequentially engaged as the actuator is moved between a plurality of predetermined settings (paragraph 0063, paragraph 0065, lines 32-35) corresponding to predetermined distances between an end portion of the outer catheter 38 and an end portion of the inner catheter 36, further wherein the handle 28 comprises a visual indicator 60 (paragraph 0073, lines 11-13) of the predetermined settings indicating a position of the actuator and configured to determine a desired distance to move the actuator for the purpose of having improved ways of controlling and providing indication of balloon length (paragraph 0010).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the apparatus of Garrison to incorporate a handle, configured to allow for single handed operation of the apparatus, the handle comprising an actuator on the handle that includes a set of protrusions that are configured to be sequentially engaged as the actuator is moved between a plurality of predetermined settings corresponding to predetermined distances between an end portion of the outer catheter and an end portion of the inner catheter, further wherein the handle comprises a visual indicator of the predetermined settings indicating a position of the actuator as taught by Andreas for the purpose of having improved ways of controlling and providing indication of balloon length (paragraph 0010).
While Andreas discloses the visual indicator 60 could include alphanumeric symbols or other appropriate indicators (paragraph 0063, lines 2-5), Garrison modified in view of Andreas is silent regarding a set of protrusions and wherein the visual indicator corresponds with the protrusions associated with the plurality of predetermined settings.
However, Looper teaches a design of a catheter allowing variable dosing including a set of markings and visual indicator 21 (figure 1) comprising a set of protrusions (paragraph 0017, lines 1-4) and wherein the visual indicator (examiner construes that “visual indicator” corresponds to the numbers associated with the lines and protrusions refers to lines in graduated marking) corresponds with the protrusions associated with the plurality of predetermined settings for the purpose of using a well-known approaches in placing the protrusions and visual markers on medical device (paragraph 0017, figure 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the set of markings and visual indicator of Garrison in view of Andreas to incorporate a set of protrusions and wherein the visual indicator corresponds with the protrusions associated with the plurality of predetermined settings as taught by Looper for the purpose of using a well-known approach in placing the protrusions and visual markers on medical device (paragraph 0017, figure 1).
Garrison in view of Andreas is silent regarding wherein the desired distance corresponds to a distance of a target vessel configured to individualize delivery of the therapeutic materials to anatomy of a patient.
However, Garrison focuses on varying the space between the balloons (paragraph 0043) to provide localized delivery in the desired isolated space (paragraph 0007). Andreas discloses the use of actuator to vary the distance between the between an end portion of the outer catheter and an end portion of the inner catheter. Additionally, the limitation wherein the desired distance corresponds to a distance of a target vessel configured to individualize delivery of the therapeutic materials to an anatomy of a patient. Therefore, Garrison modified in view of Andreas would result in a modified device which is capable to determine a desired distance wherein the desired distance corresponds to a distance of a target vessel configured to individualize delivery of the therapeutic materials to an anatomy of a patient.
Regarding claim 13, Garrison discloses the distance between the first occluder and the second occluder is adjustable (paragraph 0065, lines 5-8). However, Garrison does not explicitly disclose the distance between the first occluder and the second occluder is adjustable between one of more of: 3 cm and 15 cm and 3 cm and 22 cm.
There is no evidence of record that establishes that changing the distance would result in a difference in a function of Garrison. Further, a person having ordinary skill in the art, being faced with modifying the distance between the first occluder and the second occluder would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended being given the claimed distance range. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be within the claimed range, and offering other ranges (3 cm to 22 cm, paragraph 0073) and therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distance of Garrison to have the distance between one or more of: 3 cm and 15 cm and 3 cm and 22 cm as an obvious matter of design choice within the skill of the art.
Claim 13 further recites further wherein the distance corresponds to a spacing of one or more of: pancreatic arteries including the pancreatic magnum artery, dorsal pancreatic artery and a splenic artery. However, the term “distance” is not positively claimed as a part of the claimed invention and furthermore, the device of Garrison when inserted into the pancreatic arteries including the pancreatic magnum artery, dorsal pancreatic artery and a splenic artery is capable to provide distance corresponding to the spacing in one of the pancreatic arteries.
Regarding claim 14, Garrison discloses further comprising a pressure sensor (paragraph 0010, lines 12-15, paragraph 0045, lines 11-15) configured to measure a fluid pressure within the segment of the vessel isolated by the first occluder and the second occluder.
Regarding claim 16, Garrison discloses wherein the first occluder 3 and the second occluder 5 are each configured to be transitioned from the collapsed configuration (configuration where elements 3 and 5 are not expanded) to an expanded configuration (configuration where elements 3 and 5 are inflated), the first occluder 3 and the second occluder 5 isolating the segment of the vessel when each of the first occluder and the second occluder are in the expanded configuration (see figure 8A, the embodiment shown in figure 8A is different but the function of all the disclosed embodiments are the same).
Regarding claim 17, Garrison discloses the adapter includes a third port (any of the unlabeled port in 2A above) and discloses the lumen 14 in communication with the second occluder but is silent regarding a third port fluidically coupled to the second occluder, the third port configured to convey an inflation medium to the second occluder to transition the second occluder from its collapsed configuration to its expanded configuration.
However, Zadno-Azizi discloses a third port 118 fluidically coupled to the second occluder 126, the third port 118 configured to convey an inflation medium to the second occluder to transition the second occluder from its collapsed configuration to its expanded configuration (paragraph 0068, lines 11-14) for the purpose of using the ports to control the inflation of the second occluder (paragraph 0068, lines 11-14).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the use of ports of Garrison to include a third port fluidically coupled to the second occluder, the third port configured to convey an inflation medium to the second occluder to transition the second occluder from its collapsed configuration to its expanded configuration as taught by Zadno-Azizi for the purpose of using the ports to control the inflation of the second occluder (paragraph 0068, lines 11-14).
Regarding claim 18, Garrison discloses the use of pressure sensor for monitoring an infusion pressure within the isolated segment of the vessel between the first occluder and the second occluder (paragraph 0010, lines 12-15, paragraph 0045, lines 11-15) but is silent regarding comprising a pressure monitor in line with the infusion aperture and through which an infusion pressure within the isolated segment of the vessel between the first occluder and the second occluder can be measured in one embodiment.
However, Garrison discloses in a different embodiment (figure 8B) comprising aa pressure monitor in line with the infusion aperture 34 and through which an infusion pressure within the isolated segment of the vessel between the first occluder and the second occluder can be measured (paragraph 0056, lines 5-12) for the purpose of regulating the pressure if needed using the measured pressure (paragraph 0018).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the apparatus of one embodiment of Garrison to include a pressure monitor in line with the infusion aperture and through which an infusion pressure within the isolated segment of the vessel between the first occluder and the second occluder can be measured as taught by different embodiment of Garrison for the purpose of regulating the pressure if needed using the measured pressure (paragraph 0018).
Regarding claim 19, Garrison discloses wherein a distance between the first occluder and the second occluder being adjustable (paragraph 0006, lines 11-15).
Regarding claim 20, Garrison discloses an apparatus (figure 1A) comprising:
an inner catheter 2 defining an inner catheter lumen 17 (figures 3, 4, 7) configured to receive a guidewire (paragraph 0045, lines 8-11);
a first occluder 3 coupled to the inner catheter 2 at a first axial location (location where element 2 is positioned with respect to element 3) along the inner catheter 2;
an outer catheter 4 including a side wall (wall of element 19A forming element 20 in figure 5) defining an infusion aperture (an aperture in element 20 that delivers the fluid, furthermore, claim recites the term “defining” which do not necessarily mean to have an infusion aperture located on sidewall only, instead examiner construes the term “defining” as being able to define at least a portion of an aperture. In Garrison, sidewall of element 20 is at least partially defining the opening through which fluid gets delivered), the outer catheter 4 defining a first lumen 20 in fluid communication with the infusion aperture (opening in element 20 delivering the fluid to the patient) and a second lumen 13 (paragraph 0047), at least a portion of the inner catheter 2 being slidably disposed within the second lumen 13;
a second occluder 5 coupled to the outer catheter 4 at a second axial location (location of element 5 with respect to element 4) along the catheter device (figure 1A), the second axial location spaced apart from the first axial location (figure 1A) such that the infusion aperture is between the first occluder and the second occluder (paragraph 0013, lines 7-10, the opening in element 20 has to be located between elements 3 and 5 in order to deliver the fluid to an isolated segment of the vessel), the first occluder and the second occluder being configured to isolate a segment of a vessel (paragraph 0013, lines 7-10), wherein a distance between the first occluder and the second occluder being adjustable (paragraph 0006, lines 11-15); and
an adapter (see “A” in fig. 2A above) coupled to the outer catheter 4, the adapter including a first port (see “FP” in figure 2A above) and a second port (see “SP” in figure 2A above); a pressure transducer (paragraph 0045, lines 1-3) configured to detect a pressure within the target vessel between the first occluder 3 and the second occluder 5 and configured to guide delivery of the therapeutic material to the one or more target vessels (paragraph 0019, lines 2-13, “configured to guide delivery” is pretty broad term and would also mean to recite rate of delivery to prevent exceeding maximum pressure as explained by Garrison) but is silent regarding the first port in fluid communication with the first lumen through which a therapeutic agent can be conveyed to a segment of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen.
However, Zadno-Azizi teaches a design of a catheter (figure 3) comprising an adapter 112 having the first port 120 and the second port 123, the first port in fluid communication with the lumen 130 through which a therapeutic agent can be conveyed to a segment of the vessel (paragraph 0068, lines 14-17) and the second port 123 in fluid communication with the lumen 130 for the purpose of using the ports to introduce therapeutic agents into the patient’s body and the medical device (paragraph 0068, lines 2-17).
Examiner further construes that even though Zadno-Azizi discloses the use of different port to access same lumen 130, Garrison discloses different lumen and ports. Therefore, one of ordinary skill in the art, modifying the device of Garrison in view of Zadno-Azizi would result in having the first port in fluid communication with the first lumen through which a therapeutic agent can be conveyed to a region of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to define the function of the ports of the device of Garrison to incorporate the first port in fluid communication with the first lumen through which a therapeutic agent can be conveyed to a region of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen as taught by Zadno-Azizi for the purpose of using the ports to introduce therapeutic agents into the patient’s body and the medical device (paragraph 0068, lines 2-17).
Garrison is silent regarding a handle, configured to allow for single handed operation of the apparatus, the handle comprising an actuator on the handle that includes a set of protrusions that are configured to be sequentially engaged as the actuator is moved between a plurality of predetermined settings corresponding to predetermined distances between an end portion of the outer catheter and an end portion of the inner catheter, further wherein the handle comprises a visual indicator of the predetermined settings indicating a position of the actuator and configured to determine a desired distance to move the actuator.
However, Andreas teaches a design of devices and methods for controlling and indicating the length of an interventional element comprising a handle 28 (figure 2A, examiner construes element 56 being part of element 28), configured to allow for single handed operation of the apparatus (element 28 would allow single handed operation), the handle 28 comprising an actuator 58 on the handle that includes a set of markings 60 that are configured to be sequentially engaged as the actuator is moved between a plurality of predetermined settings (paragraph 0063, paragraph 0065, lines 32-35) corresponding to predetermined distances between an end portion of the outer catheter 38 and an end portion of the inner catheter 36, further wherein the handle 28 comprises a visual indicator 60 (paragraph 0073, lines 11-13) of the predetermined settings indicating a position of the actuator and configured to determine a desired distance to move the actuator for the purpose of having improved ways of controlling and providing indication of balloon length (paragraph 0010).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the apparatus of Garrison to incorporate a handle, configured to allow for single handed operation of the apparatus, the handle comprising an actuator on the handle that includes a set of protrusions that are configured to be sequentially engaged as the actuator is moved between a plurality of predetermined settings corresponding to predetermined distances between an end portion of the outer catheter and an end portion of the inner catheter, further wherein the handle comprises a visual indicator of the predetermined settings indicating a position of the actuator as taught by Andreas for the purpose of having improved ways of controlling and providing indication of balloon length (paragraph 0010).
While Andreas discloses the visual indicator 60 could include alphanumeric symbols or other appropriate indicators (paragraph 0063, lines 2-5), Garrison modified in view of Andreas is silent regarding a set of protrusions and wherein the visual indicator corresponds with the protrusions associated with the plurality of predetermined settings.
However, Looper teaches a design of a catheter allowing variable dosing including a set of markings and visual indicator 21 (figure 1) comprising a set of protrusions (paragraph 0017, lines 1-4) and wherein the visual indicator (examiner construes that “visual indicator” corresponds to the numbers associated with the lines and protrusions refers to lines in graduated marking) corresponds with the protrusions associated with the plurality of predetermined settings for the purpose of using a well-known approaches in placing the protrusions and visual markers on medical device (paragraph 0017, figure 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the set of markings and visual indicator of Garrison in view of Andreas to incorporate a set of protrusions and wherein the visual indicator corresponds with the protrusions associated with the plurality of predetermined settings as taught by Looper for the purpose of using a well-known approach in placing the protrusions and visual markers on medical device (paragraph 0017, figure 1).
Garrison in view of Andreas is silent regarding wherein the desired distance corresponds to a distance of a target vessel configured to individualize delivery of the therapeutic materials to anatomy of a patient.
However, Garrison focuses on varying the space between the balloons (paragraph 0043) to provide localized delivery in the desired isolated space (paragraph 0007). Andreas discloses the use of actuator to vary the distance between the between an end portion of the outer catheter and an end portion of the inner catheter. Additionally, the limitation wherein the desired distance corresponds to a distance of a target vessel configured to individualize delivery of the therapeutic materials to an anatomy of a patient. Therefore, Garrison modified in view of Andreas would result in a modified device which is capable to determine a desired distance wherein the desired distance corresponds to a distance of a target vessel configured to individualize delivery of the therapeutic materials to an anatomy of a patient.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison et al. (US 2005/0059931 A1) in view of Andreas et al. (US 2005/0149159 A1) in view of Zadno-Azizi et al. (US 2002/0016565) in view of Looper et al. (US 2013/0281971 A1) and further in view of Slater et al. (US 2006/0149218 A1).
Regarding claim 15, modified Garrison/Zadno-Azizi (hereinafter referred as “modified Garrison ‘31”) discloses the claimed invention substantially as claimed, as set forth above in claim 12. Modified Garrison ’31 is silent regarding further comprising a seal coupled to the outer catheter between the inner catheter and the outer catheter, the seal configured to prevent therapeutic material from entering the second lumen of the outer catheter.
However, Slater teaches a design (figure 34) of treating the interior of a blood vessel comprising a seal 1104 (figure 34) coupled to the outer catheter 1100 between the inner catheter 1102 and the outer catheter 1100, the seal 1104 configured to prevent therapeutic material (material infused into element 1100) from entering the second lumen of the outer catheter for the purpose of preventing the flow of the fluid out from the distal end of the second lumen (figure 34, paragraph 0152, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the apparatus of modified Garrison ’31 to incorporate further comprising a seal coupled to the outer catheter and configured to prevent therapeutic material from entering the second lumen of the outer catheter as taught by Slater for the purpose of preventing the flow of the fluid out from the distal end of the second lumen (figure 34, paragraph 0152, lines 1-4).
Response to Arguments
Applicant's arguments filed 5/4/2026 have been fully considered but they are not persuasive.
Applicant argues on page 10, line 1-page 11, line 5 that the combination of the prior art fails to disclose the claim as amended. Examiner respectfully disagrees. The added limitation in independent claim is drawn towards functional limitation and the modified device formed by the combination of the prior art is capable to perform the claimed functional limitation. Therefore, as explained in the rejection above in the current Office Action, the prior art discloses each and every limitation of the claimed limitation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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