DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 7/8/2026 has been entered. Claims 29-49 are pending in the application. Applicant’s amendments to the Specification and Claims have not overcome each and every objection previously set forth in the Non-Final Office Action mailed 5/4/2026.
Specification
The amendment filed 7/8/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The proposed amendment to paragraph [0037] of the specification, as filed on 7/8/2026, are new matter. As originally disclosed, Figure 5 and paragraph [0037] disclose a balloon catheter 555. The amendment changes the structure of the catheter, with the balloon 555 now being delivered through catheter 554. A balloon catheter and a catheter configured to deliver a balloon are different, distinct structures. A catheter configured to deliver a balloon and a therapy through the same lumen also includes distinct structure that is not synonymous to a balloon catheter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the at least one access device through which a therapy and a medical device is delivered through the same lumen, subject matter of amended claim 29, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 40 is objected to because of the following informalities:
Regarding claim 40, “the ECA” should be corrected to “an external carotid artery (ECA) of the patient” for claim language consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 33 and 45-46 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As amended, claim 29 recites the limitation of “…with the curved distal segment at the predetermined location and in the retrograde direction…”. Claim 33, dependent on claim 29, includes the limitation of “…wherein the adjacent blood vessel comprises a middle meningeal artery (MMA) of the patient's vasculature system, and wherein the method further comprises delivering the therapy and the medical device through the lumen and the curved distal segment of the at least one access device to the MMA”. This combination of limitations is not supported by the original disclosure and is considered new matter. Physiologically, the curved distal segment cannot be positioned in a retrograde direction and in the MMA, when originating from the STA. The curved distal segment would have to be positioned in an antegrade direction when positioned in the MMA.
As amended, claim 29 recites the limitation of “…with the curved distal segment at the predetermined location and in the retrograde direction…”. Claim 45, dependent on claim 29, includes the limitation of “treating an arteriovenous malformation within… a middle meningeal artery (MMA)…”. This combination of limitations is not supported by the original disclosure and is considered new matter. In order to access the MMA, when originating from the STA, the curved distal segment would have to be positioned in an antegrade direction.
As amended, claim 29 recites the limitation of “…with the curved distal segment at the predetermined location and in the retrograde direction…”. Claim 46, dependent on claim 29, includes the limitation of “…wherein the method further comprises delivering the therapy and the medical device up a middle meningeal artery (MMA) of the patient”. This combination of limitations is not supported by the original disclosure and is considered new matter. In order to access the MMA, when originating from the STA, the curved distal segment would have to be positioned in an antegrade direction.
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) 29-30, 32, 34, 38-45, and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doyle (US 20050228359 A1), and Sepetka (US 4955862 A) the content of which is incorporated in its entirety by reference, in view of Calhoun (US 20200206482 A1), and further in view of Garrison (US 20130281788 A1).
Regarding claims 29, 32, and 49, Doyle discloses a method of delivering a therapy by trans-maxillary access (abstract), the method comprising: inserting a guide wire into a superficial temporal artery (STA) of a patient in a retrograde direction; inserting one or more access devices into the STA along a path traversed by the guide wire in the retrograde direction (insertable catheter 120 is introduced into the superficial temporal artery (STA) 50 in a retrograde direction, [0043]-[0044] & Fig. 5 and 6A/B; catheter assembly 140, which includes catheter 141, may be used instead of catheter 120, [0053] and [0057]-[0059] & Fig. 7A/B; catheter 10 of Sepetka, which is in reference to catheter 141 of Doyle, employs a guide wire 14, Col 4 lines 1-12 & Fig. 1; “The catheter of the present invention is designed for advancement along a guide wire which has been placed, by movement along a tortuous path, in a highly convoluted bent and/or coiled configuration”, Col 9 lines 8-11 & Fig. 1 and 10-11 of Sepetka; retrograde insertion of catheter 141 would inherently include the insertion of guide wire 14 in the retrograde direction beforehand);
advancing at least one access device of the one or more access devices until a curved distal segment of the at least one access device reaches a predetermined location within a vasculature system of the patient (distal end 142, which is seen as having a slight curve in Figs. 7A/B, of catheter 141 advanced to a predetermined location, for example bifurcation 110 or just short of bifurcation 110, see [0044] and [0053] & Figs. 7A/7B; catheter 10 of Sepetka also disclosed as being able to bend and having a curved distal segment upon reaching a desired location, Col 12 lines 25-31 and lines 40-48 & Fig. 11-12 of Sepetka) to provide access to an adjacent blood vessel (“After the external carotid artery 47 has been catheterized, the catheter 120 is the[n] advanced toward the bifurcation 110 of the ipsilateral external and internal carotid arteries 47, 90, in a direction that is retrograde to physiological blood flow”, [0044] & Fig. 6A/6B and 7A/B); and
with the curved distal segment at the predetermined location and in the retrograde direction: delivering the therapy to the adjacent blood vessel through a lumen of the at least one access device and through the curved distal segment (catheter 141 used to deliver cool fluid through lumen 149 at distal end 142 to bifurcation 110 and internal carotid artery 90 once the curved distal end 142 is positioned, [0044]-[0045] and [0058] & Fig. 7A/B and 9; “in one approach, a balloon catheter assembly 140 is percutaneously introduced into a branch of the external carotid artery 47 and advanced toward but just short of the bifurcation 110, leaving a short distance between the catheter distal end 142 and the bifurcation 110. After the distal end 142 has been positioned at or near the bifurcation 110…”, [0053]; the curved distal end 142 is positioned just short of the bifurcation 110, in the retrograde direction, [0044]).
However, Doyle fails to explicitly disclose the curved distal segment forming an angle of about 45 degrees or about 180 degrees with a remaining portion of the at least one access device and delivering a medical device to the adjacent blood vessel through the lumen and through the curved distal segment.
However, Calhoun teaches a method of delivering a therapy by trans-maxillary access (abstract & Fig. 32C; the method includes retrograde access of the STA, [0208]), the method comprising at least one access device (microcatheter 610, [0177] & Fig. 21A) comprising a curved distal segment forming an angle of about 45 degrees or about 180 degrees with a remaining portion of the at least one access device (“The distal tip 630 of the microcatheter 610 may be straight or may be curve-shaped as shown in FIGS. 23A-23F. The distal tip 630 may be formed to have an anatomically relevant shape such as a 45-degree bend, a 90-degree bend, a 180-degree bend, a shepherd's hook shape... Other shapes may be used depending on the specific anatomy being navigated. These shapes maybe pre-formed by the manufacturer or by the physician during use”, [0180] & Fig. 23A-23F).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the curved distal segment of the catheter of Doyle with Calhoun to include an angle of about 45 degrees or about 180 degrees with a remaining portion of the at least one access device, since such a modification would help a physician navigate the tortuous anatomy of accessed blood vessels, such as the ICA and STA, and is taught by Calhoun to be an art effective configuration for the distal end of a catheter configured for retrograde access of the STA (see [0180], [0205], [0222]-[0023] & Fig. 31A-31B and 37).
Further, Garrison teaches a method of delivering a therapy by trans-maxillary access (abstract and [0058] & Fig. 1-4) comprising delivering a therapy and a medical device, wherein the medical device comprises a retriever, to the adjacent blood vessel through the lumen and through the curved distal segment (inner member 2652 which “may perform some or all of the functions that a microcatheter would do during a stroke interventional procedure, for example cross the occlusion to perform distal angiograms, inject intraarterial thrombolytic agents into the clot, or deliver mechanical thrombectomy devices such as coil retrievers or stent retrievers, [0077] & Fig. 8-9; a stent or coil retriever 4100 is taught in [0050] and [0099]-[0101] & Fig. 22).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Doyle, as modified, with Garrison to include delivering a medical device, wherein the medical device comprises a retriever, to the adjacent blood vessel through the lumen since such a modification would provide means to help remove an occlusion/thrombus during a thrombectomy procedure ([0050], [0077], and [0133] of Garrison).
As modified, catheter 120/141 of Doyle would be configured to allow passage of a retriever for use during a thrombectomy procedure, the retriever necessarily passing through the curved distal end 142 to exit the catheter.
Regarding claim 30, Doyle, as modified, discloses all the limitations of claim 29. Doyle further discloses the method wherein the one or more access devices comprise a sheath (catheter 141 can alternatively be interpreted as a sheath, a sheath being a flexible tube introduced into a vessel, [0043]).
Regarding claim 34, Doyle, as modified, discloses all the limitations of claim 29. Doyle further discloses the method wherein the adjacent blood vessel comprises an internal carotid artery (ICA) of the patient's vasculature system (“After the external carotid artery 47 has been catheterized, the catheter 120 is the advanced toward the bifurcation 110 of the ipsilateral external and internal carotid arteries 47, 90, in a direction that is retrograde to physiological blood flow”, [0044] & Fig. 7A/B).
Regarding claim 38, Doyle, as modified, discloses all the limitations of claim 29. Doyle further discloses the method further comprising advancing a catheter into at least one of a heart, a coronary vessel, and a maxillary vascular system of the patient (“The methods and systems described herein can also be adapted for use in high-risk patients undergoing coronary artery bypass surgery”, [0070]; this procedure would necessitate addressing the heart and coronary vessels; also see [0033] and [0035]).
Regarding claim 39, Doyle, as modified, discloses all the limitations of claim 29. Doyle further discloses the method further comprising advancing the one or more access devices from the STA into an external carotid artery (ECA) of the patient (catheter is introduced into the superficial temporal artery (STA) 50, [0043] and [0058] & Fig. 5 and 7A; this is done to access the external carotid artery 47; “After the external carotid artery 47 has been catheterized, the catheter 120 is the advanced toward the bifurcation 110 of the ipsilateral external and internal carotid arteries 47, 90, in a direction that is retrograde to physiological blood flow”, [0044] & Fig. 7A/B).
Regarding claim 40, Doyle, as modified, discloses all the limitations of claim 29. Doyle further discloses the method wherein the adjacent blood vessel comprises an internal carotid artery (ICA) of the patient, and wherein the method further comprises delivering the therapy to the ICA through the ECA (see [0047] & Fig. 7A/B; “The cool fluid 130 is preferably pushed or pumped into external carotid artery 47 with enough pressure to overcome the blood pressure in the external carotid artery 47, so that the cool fluid 130 is redirected into ipsilateral internal carotid artery 90 in a direction antegrade to physiologic blood flow, thereby delivering cool fluid 130 to stroke-affected regions in the ipsilateral brain hemisphere.”; fluid 130 is eluded into the ECA and then travels into the ICA as seen in Fig. 7A).
Regarding claims 41-42, Doyle, as modified, discloses all the limitations of claim 29. Doyle further discloses the method wherein the therapy comprises a thrombolytic drug or a non-thrombolytic drug (see [0050]).
Regarding claim 43, Doyle, as modified, discloses all the limitations of claim 29. Doyle further discloses the method further comprising locating the STA underneath a scalp of the patient using ultrasound imaging (“The catheter 120 is preferably advanced and positioned using any known suitable visualization technique, such as, for example, ultrasound imaging, fluoroscopy, radiography, etc.”, [0044]).
Regarding claim 44, Doyle, as modified, discloses all the limitations of claim 29. However, Doyle fails to explicitly disclose the method further comprising treating epistaxis. However, Doyle does disclose the introduction of cool fluid 130 to a targeted treatment site (abstract). The internal carotid artery (ICA), which is accessed by the disclosed method in Doyle, connects to the nose (see [0033] and [0045]) and is provided with cool fluid 130 (see [0045]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the method of Doyle to treat epistaxis considering it is well known in the art that cold temperatures can help manage epistaxis and the cool fluid introduced by the method is introduced into the ICA which directly connects to the nose.
Regarding claim 45, Doyle, as modified, discloses all the limitations of claim 29. Doyle further discloses the method further comprising treating an arteriovenous malformation within an external carotid artery (ECA), an internal carotid artery (ICA), and/or a maxillary vascular system of the patient (strokes can occur due to arteriovenous malformation bleeding, see [0008]; the method and system of the invention intended to treat stroke-affected regions of the brain, see [0012] and [0044]-[0045]).
Claim(s) 33 and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doyle (US 20050228359 A1), and Sepetka (US 4955862 A) the content of which is incorporated in its entirety by reference, in view of Calhoun (US 20200206482 A1), in view of Garrison (US 20130281788 A1), and further in view of Vidlund (US 20190262000 A1).
Regarding claim 33, Doyle discloses all the limitations of claim 29. Doyle discloses “a method of selectively inducing hypothermia in the brain hemisphere where the stroke has occurred… there is provided a method for treating stroke by introducing cooled fluid into a brain hemisphere that has been blood-deprived as a result of the stroke. In one approach, the method for introducing cooled fluid generally comprises: introducing a catheter into a branch artery of the external carotid artery that is ipsilateral to the brain hemisphere; advancing the catheter along the branch artery in a direction retrograde to physiological blood flow; and introducing cool fluid through the catheter opening such that the fluid flows into the ipsilateral internal carotid artery in a direction antegrade to physiologic blood flow.” ([0039]-[0040]). “After the catheter 120 has been positioned near the bifurcation 110, a cool fluid 130 is introduced through the catheter opening 124 and into the ipsilateral internal carotid artery 90 in a direction antegrade to physiologic blood flow, thereby delivering cool fluid 130 to stroke-affected regions in the ipsilateral brain hemisphere.” ([0045]). “The fluid 130 comprises a mixture of cool saline and a stroke-treating medication, such as an…thrombolytic.” ([0050]). The internal carotid artery receives the thrombolytic because the ICA is connected to a stroke-affected region of a brain hemisphere or is occluded and being treated for stroke prevention ([0008]).
However, Doyle fails to explicitly disclose the method wherein the adjacent blood vessel comprises a middle meningeal artery (MMA) of the patient's vasculature system, and wherein the method further comprises delivering the therapy and the medical device through the lumen and the curved distal segment of the at least one access device to the MMA.
However, Vidlund teaches a method (abstract) wherein the adjacent blood vessel comprises a middle meningeal artery (MMA) of the patient's vasculature system (distal end 52 of catheter 50 may be advanced into the external carotid artery 8 and then be positioned within the middle meningeal artery 24, whereafter a pharmaceutical agent 60, such as a thrombolytic, is delivered, [0027]-[0028] & Fig. 1-2).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Doyle, as modified, with Vidlund to include the adjacent blood vessel comprising a middle meningeal artery (MMA) of the patient's vasculature system since the middle meningeal artery is taught by Vidlund to be a catheter accessible artery that may be targeted for delivery of a thrombolytic for “treating a blockage, a stenosis, a lesion, plaque, or other physiology in the ophthalmic artery or a junction between the ophthalmic artery and the internal carotid artery” as deemed desired or necessary for patient treatment by a medical professional (see [0008], [0023], [0027]-[0028], and [0032] of Vidlund). As modified, the MMA would receive the cool fluid containing the thrombolytic as the MMA is a suitable artery to be accessed for treatment and can be reached through the STA ([0022] and [0027] & Fig. 2 of Vidlund). As modified, the therapy and medical device would still be delivered through catheter 141 of Doyle.
Regarding claim 46, Doyle discloses all the limitations of claim 29. Doyle further discloses the method wherein inserting the one or more access devices into the STA comprises inserting the one or more access devices with a retrograde approach down the superficial temporal artery (STA) (insertable catheter is introduced into the superficial temporal artery (STA) 50 in a retrograde direction, [0043]-[0044] and [0058] & Fig. 5 and 7A/B).
Doyle further discloses “a method of selectively inducing hypothermia in the brain hemisphere where the stroke has occurred… there is provided a method for treating stroke by introducing cooled fluid into a brain hemisphere that has been blood-deprived as a result of the stroke. In one approach, the method for introducing cooled fluid generally comprises: introducing a catheter into a branch artery of the external carotid artery that is ipsilateral to the brain hemisphere; advancing the catheter along the branch artery in a direction retrograde to physiological blood flow; and introducing cool fluid through the catheter opening such that the fluid flows into the ipsilateral internal carotid artery in a direction antegrade to physiologic blood flow.” ([0039]-[0040]). “After the catheter 120 has been positioned near the bifurcation 110, a cool fluid 130 is introduced through the catheter opening 124 and into the ipsilateral internal carotid artery 90 in a direction antegrade to physiologic blood flow, thereby delivering cool fluid 130 to stroke-affected regions in the ipsilateral brain hemisphere.” ([0045]). “The fluid 130 comprises a mixture of cool saline and a stroke-treating medication, such as an…thrombolytic.” ([0050]). The internal carotid artery receives the thrombolytic because the ICA is connected to a stroke-affected region of a brain hemisphere or is occluded and being treated for stroke prevention ([0008]).
However, Doyle fails to explicitly disclose the method wherein the method further comprises delivering the therapy and the medical device up a middle meningeal artery (MMA) of the patient. However, Vidlund teaches a method (abstract) wherein the method further comprises delivering the therapy up a middle meningeal artery (MMA) of the patient (distal end 52 of catheter 50 may be advanced into the external carotid artery 8 and then be positioned within the middle meningeal artery 24, whereafter a pharmaceutical agent 60, such as a thrombolytic, is delivered, [0027]-[0028] & Fig. 1-2; the MMA is disclosed as receiving antegrade blood flow, [0031] & Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Doyle, as modified, with Vidlund to include delivering the therapy up a middle meningeal artery (MMA) of the patient since the middle meningeal artery is taught by Vidlund to be a catheter accessible artery that may be targeted for delivery of a thrombolytic for “treating a blockage, a stenosis, a lesion, plaque, or other physiology in the ophthalmic artery or a junction between the ophthalmic artery and the internal carotid artery” as deemed desired or necessary for patient treatment by a medical professional (see [0008], [0023], [0027]-[0028], and [0032]of Vidlund). As modified, the MMA would receive the cool fluid containing the thrombolytic as the MMA is a suitable artery to be accessed for treatment and can be reached through the STA ([0022] and [0027] & Fig. 2 of Vidlund). As modified, the therapy and medical device would still be delivered through catheter 141 of Doyle.
Claim(s) 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doyle (US 20050228359 A1), and Sepetka (US 4955862 A) the content of which is incorporated in its entirety by reference, in view of Calhoun (US 20200206482 A1), in view of Garrison (US 20130281788 A1), and further in view of Pisarik (US 5415647 A).
Regarding claims 35-36, Doyle, as modified, discloses all the limitations of claim 29. However, Doyle fails to explicitly disclose the method further comprising placing a forked device on a scalp of the patient for stabilizing the STA, and the method further comprising pinning the STA in place using the forked device.
However, Pisarik teaches a method (see claim 10) comprising placing a forked device on a scalp of the patient for stabilizing the STA (vascular immobilizer 66 including groove 68 forming branches, Col 5 lines 41-48 & Fig. 5A and 6; immobilizer 66 is being interpreted as the forked device; the vascular immobilizer 66 disclosed as being flexible allowing it to contour to different surfaces, such as a scalp, Col 4 line 33; “Then mild pressure with one hand can be used to hold immobilizer 66 in this configuration while needle 80 then is introduced into superficial vein 70 with the other hand, at a point close to immobilizer 66 as shown in FIG. 6.”, see Col 6 lines 59-68 and Col 7 lines 1-8 & Fig. 6; the immobilizer 66 would be placed onto the blood vessel before the blood vessel is accessed), and
the method further comprising pinning the STA in place using the forked device (immobilizer 66 configured to stabilize a blood vessel in place, Col 4 lines 39-42 & Fig. 6; the Examiner notes that the STA is not explicitly mentioned but Pisarik discloses immobilizing devices needed for the immobilization of veins and arteries, see Col 1 lines 12-17, and a related device for holding arteries, Col 3 lines 10-12).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Doyle, as modified, with Pisarik to include placing a forked device on a scalp of the patient for stabilizing the STA, and the method further comprising pinning the STA in place using the forked device, since such a modification would provide structure to more easily access the blood vessel and yield predictable results pertaining to vessel stabilization before access (see Col 4 lines 39-40 and Col 5 lines 40-46 of Pisarik).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doyle (US 20050228359 A1), and Sepetka (US 4955862 A) the content of which is incorporated in its entirety by reference, in view of Calhoun (US 20200206482 A1), in view of Garrison (US 20130281788 A1), and further in view of Wright (US 20100179482 A1).
Regarding claim 37, Doyle, as modified, discloses all the limitations of claim 29. However, Doyle fails to explicitly disclose the method further comprising docking an infusion port on or under a scalp of the patient for long term infusion of one or more medications via a needle access.
However, Wright teaches a method (abstract) further comprising docking an infusion port on a scalp of the patient for long term infusion of one or more medications via a needle access (securing device 520 having base 526 contoured to match the anatomy of the scalp where a catheter is inserted, see [0125] & Fig. 54; the securing device meant to help secure a catheter for long term use, see [0002]; the catheter inserted via needle access is well known in the art, see [0002]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Doyle, as modified, with Wright to include docking an infusion port on a scalp of the patient for long term infusion of one or more medications via a needle access since such a modification would provide a universal securing means for the catheter to help hold the catheter in place and prevent substantial rotational, longitudinal, or lateral movement of the catheter during use and yield predictable results pertaining to improved catheter use (see abstract and [0126] of Wright). As combined, the securing device 520 of Wright would be secured onto the scalp of the subject and used alongside catheter 141 of Doyle.
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doyle (US 20050228359 A1), and Sepetka (US 4955862 A) the content of which is incorporated in its entirety by reference, in view of Calhoun (US 20200206482 A1), and further in view of Garrison (US 20130281788 A1), and further in view of Pansky (US 20090292296 A1).
Regarding claim 47, Doyle, as modified, discloses all the limitations of claim 29. However, Doyle fails to explicitly disclose the method further comprising delivering negative and positive pressures to the vasculature system by the one or more access devices.
However, Pansky teaches the method (abstract) further comprising delivering negative and positive pressures to the vasculature system by the one or more access devices (distal active bellows 41, [0059] & Fig. 1B; used to break apart occlusion to further advance a catheter 20a, Fig. 4A; “the mechanical plunger 18 which in turn delivers to the proximal bellows 42 at least one energy pulse to the proximal bellows 42, contracting the proximal bellows 42 to generate a hydraulic wave that moves distally through the hydraulic lumen 40 causing the distal bellows 41 to expand”, [0059] & Fig. 1B; the hydraulic wave is being interpreted as a combination of negative and positive pressure pulses, see [0028], [0041], and [0059]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Doyle, as modified, with Pansky to include delivering negative and positive pressures to the vasculature system by the one or more access devices since such a modification would provide means for re-canalization or opening of a passage through an occlusion in a blood vessel in an adjustable manner that suits the morphology or hardness of the target occlusion and yield predictable results pertaining to occlusion clearance in a blood vessel (see abstract and [0027] of Pansky).
Claim(s) 31 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doyle (US 20050228359 A1), and Sepetka (US 4955862 A) the content of which is incorporated in its entirety by reference, in view of Calhoun (US 20200206482 A1), and further in view of Garrison (US 20130281788 A1), and further in view of Tal (US 20110004162 A1).
Regarding claims 31 and 48, Doyle, as modified, discloses all the limitations of claim 29. However, Doyle fails to explicitly disclose the method wherein the one or more access devices comprise a dilator, and the method further comprising inserting a needle into the STA prior to inserting the guide wire into the STA. However, Tal discloses a method wherein the one or more access devices comprise a dilator, and the method further comprising inserting a needle into the STA prior to inserting the guide wire into the STA (the Seldinger technique, which is well known in the art, is a method of inserting a catheter using a needle 252 and dilator 262, see [0003], [0009]-[0010], and [0041]& Fig. 9A-9B; needle insertion happening before guidewire insertion).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Doyle, as modified, with Tal to include the one or more access devices comprising a dilator, and the method further comprising inserting a needle into the STA prior to inserting the guide wire into the STA since such a modification would provide means for puncturing a blood vessel to grant access to the blood vessel and protect the needle upon removal (see [0010]-[0011] and [0014]).
Response to Arguments
Applicant's arguments filed 7/8/2026 have been fully considered but they are not persuasive. In response to Applicant’s arguments that Doyle and Sepetka do not teach the claimed vascular access via “superficial temporal artery (STA)”, the Examiner finds that Doyle explicitly discloses vascular access via the STA: “in one approach, a percutaneously insertable catheter 120 is introduced in any known suitable branch artery of the external carotid artery 47 that is ipsilateral to the stroke-affected brain hemisphere. Suitable branch arteries include, for example, the occipital artery 48, the sternocleidomastoid artery 49, the superficial temporal artery 50”, (emphasis added) see [0043] of Doyle.
In response to Applicant’s arguments that Calhoun and Garrison do not teach delivering a therapy or medical device with the curved distal segment at the predetermined location and in the retrograde direction, the Examiner finds neither Calhoun nor Garrison are relied upon to teach this 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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Prosecution Insights