DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Acknowledgment
Claims 21, 23-24, 27- 28, 31-34, 38-39 are amended and field on 8/4/2025.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The limitation of claims 21, “without moving or rotating the delivery device, inflating and deflating the balloon for a second time to press spikes... without moving or rotating the delivery device, inflating and deflating the balloon for a third time to press spikes..” in lines 6-10 has no support in the originally filed specification. Note: the specification as filed has “no repeating inflation or deflation” expect as described in ¶0057-¶0060 and Fig. 5a-5d, wherein inflate and deflate the balloon to engage some spikes of the plurality of spike located in one quadrant with the plaque, then repeat for other quadrants.
The limitation of claims 28, “without moving or rotating the delivery device, inflating and deflating the balloon for a second time to move the plurality of spikes to engage atherosclerotic plaque... without moving or rotating the delivery device, inflating and deflating the balloon for a third time to move the plurality of spikes to engage atherosclerotic plaque.. without moving or rotating the delivery device, inflating and deflating the balloon for a fourth time to move the plurality of spikes to engage atherosclerotic plaque..” in lines 8-14 has no support in the originally filed specification. Note: the specification as filed has “no repeating inflation or deflation” expect as described in ¶0057-¶0060 and Fig. 5a-5d, wherein inflate and deflate the balloon to engage some spikes of the plurality of spike located in one quadrant with the plaque, then repeat for other quadrants.
The limitation of claims 34, “without moving or rotating the delivery device, inflating and deflating the balloon for a second time to press spikes... without moving or rotating the delivery device, inflating and deflating the balloon for a third time to press spikes..” in lines 11-14 has no support in the originally filed specification. Note: the specification as filed has “no repeating inflation or deflation” expect as described in ¶0057-¶0060 and Fig. 5a-5d, wherein inflate and deflate the balloon to engage some spikes of the plurality of spike located in one quadrant with the plaque, then repeat for other quadrants.
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 21, 23-28, 30-34, 36-40 are 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.
The limitation of claims 21, “without moving or rotating the delivery device, inflating and deflating the balloon for a second time to press spikes... without moving or rotating the delivery device, inflating and deflating the balloon for a third time to press spikes..” in lines 6-10 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. Note: the specification as filed has “no repeating inflation or deflation” expect as described in ¶0057-¶0060 and Fig. 5a-5d, wherein inflate and deflate the balloon to engage some spikes of the plurality of spike located in one quadrant with the plaque, then repeat for other quadrants.
The limitation of claims 28, “without moving or rotating the delivery device, inflating and deflating the balloon for a second time to move the plurality of spikes to engage atherosclerotic plaque... without moving or rotating the delivery device, inflating and deflating the balloon for a third time to move the plurality of spikes to engage atherosclerotic plaque.. without moving or rotating the delivery device, inflating and deflating the balloon for a fourth time to move the plurality of spikes to engage atherosclerotic plaque..” in lines 8-14 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. Note: the specification as filed has “no repeating inflation or deflation” expect as described in ¶0057-¶0060 and Fig. 5a-5d, wherein inflate and deflate the balloon to engage some spikes of the plurality of spike located in one quadrant with the plaque, then repeat for other quadrants.
The limitation of claims 34, “without moving or rotating the delivery device, inflating and deflating the balloon for a second time to press spikes... without moving or rotating the delivery device, inflating and deflating the balloon for a third time to press spikes..” in lines 11-14 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. Note: the specification as filed has “no repeating inflation or deflation” expect as described in ¶0057-¶0060 and Fig. 5a-5d, wherein inflate and deflate the balloon to engage some spikes of the plurality of spike located in one quadrant with the plaque, then repeat for other quadrants.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21, 23-24, 27, 31-3, 38-39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 21 recites the limitation “without moving or rotating the delivery device, inflating and deflating the balloon for a second time to press spikes... without moving or rotating the delivery device, inflating and deflating the balloon for a third time to press spikes..” in lines 6-10. It is unclear if it means that all spikes of the plurality of spike engages the plaque for each inflating/deflating or it means some spikes of the plurality of spike will engages the atherosclerotic plaque. Note, for the purpose of examiner, the examiner will interpret the limitation as some spikes of the plurality of spike will engages the atherosclerotic plaque.
Claims 28 recites the limitation “without moving or rotating the delivery device, inflating and deflating the balloon for a second time to move the plurality of spikes to engage atherosclerotic plaque... without moving or rotating the delivery device, inflating and deflating the balloon for a third time to move the plurality of spikes to engage atherosclerotic plaque.. without moving or rotating the delivery device, inflating and deflating the balloon for a fourth time to move the plurality of spikes to engage atherosclerotic plaque..” in lines 8-14. It is unclear if it means that all spikes of the plurality of spike engages the plaque for each inflating/deflating or it means some spikes of the plurality of spike will engages the atherosclerotic plaque. Note, for the purpose of examiner, the examiner will interpret the limitation as some spikes of the plurality of spike will engages the atherosclerotic plaque.
Claims 34 recites the limitation, “without moving or rotating the delivery device, inflating and deflating the balloon for a second time to press spikes... without moving or rotating the delivery device, inflating and deflating the balloon for a third time to press spikes..” in lines 11-14, It is unclear if it means that all spikes of the plurality of spike engages the plaque for each inflating/deflating or it means some spikes of the plurality of spike will engages the atherosclerotic plaque. Note, for the purpose of examiner, the examiner will interpret the limitation as some spikes of the plurality of spike will engages the atherosclerotic plaque.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 21, 23-27, 34, 36-40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Melsheimer et al. (US.20060149308A1) (“Melsheimer”) in view of Grayzel et al. (US. 20020010489A1) (“Grayzel”).
Re Claim 21, Melsheimer discloses a method (¶0037, Figs. 2-6) comprising: positioning a delivery device at a treatment site (balloon 14 of the catheter 10, ¶0037, placed at the restriction/ plaque ¶0026), the delivery device comprising a plurality of spikes and a balloon (spikes 30 with base 32, body 34 and tip 35 and the balloon 14, Figs. 3-6, ¶0023, ¶0010), inflating the balloon to press spikes into atherosclerotic plaque at the treatment site (¶0037, the first time inflating the balloon, ¶0006 with a low pressure inflation within a vessel, ¶0009, ¶0010, abstract), deflating the balloon at the treatment site (¶0037, first deflating the balloon), without moving or rotating the delivery device, inflating the balloon for a second time to press spikes into the atherosclerotic plaque at the treatment site (¶0037, balloon can be inflated several time and may not need to be rotated or moved, inflating the balloon for the second time, ¶0006), deflating the balloon for a second time at the treatment site (¶0037, deflating the balloon for the second time), without moving or rotating the delivery device, inflating the balloon for a third time to press spikes into the atherosclerotic plaque at the treatment site (¶0037, the balloon can be inflated several time and may not need to be rotated or moved, inflating the balloon for the third time, ¶0006), and deflating the balloon for a third time at the treatment site (¶0037, deflating the balloon for the third time), wherein a plurality of spikes form prick points in the atherosclerotic plaque with a depth of penetration when actuated by inflation of the balloon (spikes 30 form a cut/penetrate the plaque, Figs. 3-6, ¶0023, ¶0010, most of the plaque will stay adhered to a wall of the vessel as the spike only cut the plaque, ¶0037), but it fails to disclose that the depth of penetration in the range of 0.01mm to 0.5 mm and wherein the plurality of spikes create prick points in a top layer of the atherosclerotic plaque without exposing the medial layer, wherein the prick points are not deep enough to cut though the plaque thickness, wherein inflating the balloon leads to the predictable formation of a cleavage line or plane in the atherosclerotic plaque.
However, Grayzel discloses a balloon catheter (44, Fig. 2, Fig. 10b-10d) and wherein the balloon the plurality of spikes (projection 48) form tiny prick points in atherosclerotic plaque (¶0053, the projection performs incising or piercing the occlusion/plaque) and a depth of penetration when actuated by inflation of the balloon (¶0011) with a depth of penetration in the range the depth of penetration in the range of 0.01mm to 0.5 mm (wherein the height of the spike is vary see ¶0066, and such as the depth of piercing can be 0.004 inch (0.1mm) to 0.015 inches (0.38 mm) see ¶0058, the piercing the occlusion to height of projection of less than the thickness of the plaque as spike height similar to the ones of the current application ) and wherein the plurality of spikes create prick points in a top layer of the atherosclerotic plaque without exposing the medial layer (as the projection/spike 48 have same height of the current application and it used only for piercing the occlusion see ¶0059), wherein the prick points are not deep enough to cut though the plaque thickness (the penetration depth is less/ or equal to the height of the projection 48 and the projection is used only for piercing the occlusion see ¶0058-¶0059), wherein inflating the balloon leads to the predictable formation of a cleavage line or plane in the atherosclerotic plaque (¶0015, ¶0077, as the spikes are arranging in lines, the spike will form a predictable of a cleavage line).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modified the spike of Melsheimer so that the depth of penetration in the range of 0.01mm to 0.5 mm and wherein the plurality of spikes create prick points in a top layer of the atherosclerotic plaque without exposing the medial layer, wherein the prick points are not deep enough to cut though the plaque thickness, wherein inflating the balloon leads to the predictable formation of a cleavage line or plane in the atherosclerotic plaque as taught by Grayzel for the purpose of utilizing a desired spike heights and specific spike’s shape for incising or piercing the plaque (Grayzel, ¶0058, ¶0015).
Re Claim 23, the modified Melsheimer discloses wherein multiple inflating of the balloon causes lower disruption of the atherosclerotic plaque, lower dissections, and lower injury to the wall of the vessel for vessel dilation compared with a vessel dilation procedure without multiple of inflating of the balloon to form atherosclerotic plaque with prick point (Grayzel, ¶0011,¶0058- ¶0059, wherein the length of the spike can be used to incise or pierce the plaque and this is lower disruption of the atherosclerotic plaque, lower dissections, and lower injury to the wall of the vessel for vessel dilation as the spikes contacts the plaque only compared with vessel dilation without multiple inflating the balloon).
Re Claim 24, the modified Melsheimer discloses wherein multiple inflating of the balloon reduces or prevents a biological reaction that often follows balloon angioplasty with neointimal hyperplasia or smooth muscle cell replication (as the spike’s height are not contacting the vessel, this inflating will recue the reaction, Grayzel, ¶0011, ¶0058, ¶0077).
Re Claim 25, the modified Melsheimer discloses wherein the prick points act as serrations along a length of the atherosclerotic plaque (the spike of the modified Melsheimer will have less line of serration in the longitudinal to the occlusion/ plaque as the spike in the longitudinal of the balloon, Melsheimer Fig. 2, Grayzel, Fig. 2).
Re Claim 26, the modified Melsheimer discloses wherein the prick points allow the cleavage line or plane to be formed in the atherosclerotic plaque under compression forces (wherein the modified Melsheimer will form the tiny prick points allow the cleavage line to be formed in the plaque under compression force as result of piercing the plaque with spikes Grayzel, Fig. 2, ¶0077).
Re Claim 27, the modified Melsheimer discloses wherein as the plurality of spikes are pressed into the atherosclerotic plaque, the atherosclerotic plaque is also compressed by a low pressure compared to the pressure of dilatation (wherein the modified spike of Melsheimer pressed into the plaque under compression force with a lower pressure see ¶0010 of Melsheimer, this compression is less compared to a compression to the plaque by a high pressurized inflated dilation balloon which is a balloon without spike, see also Grayzel, Fig. 2, ¶0011).
Re Claim 34, Melsheimer discloses a method (balloon 14 of the catheter 10, Figs. 2-6) comprising: positioning a delivery device at a treatment site (14 of the catheter 10 is inserted within a vessel balloon, ¶0037, placed at the restriction/ plaque ¶0026), the delivery device comprising a plurality of spikes and a balloon (spikes 30 with base 32, body 34 and tip 35 and the balloon 14, Figs. 3-6, ¶0023, ¶0010), and initially moving the plurality of spikes radially outward toward the treatment site (first inflation, ¶0037), without moving or rotating the delivery device, inflating and deflating the balloon for a first time to press spikes into atherosclerotic plaque at the treatment site (¶0037, the balloon can be inflated several time and may not need to be rotated or moved, inflating the balloon for the first time, ¶0006), wherein inflating and deflating the balloon is a separate action than initially moving the plurality of spikes radially outward toward the treatment site (¶0037, first inflation can be consider separate action than initial inflation, ¶0006), without moving or rotating the delivery device, inflating and deflating the balloon for a second time to press spikes into the atherosclerotic plaque at the treatment site (¶0037, the balloon can be inflated several time and may not need to be rotated or moved, inflating the balloon for the second time, ¶0006), without moving or rotating the delivery device, inflating and deflating the balloon for a third time to press spikes into the atherosclerotic plaque at the treatment site (the balloon can be inflated and then deflated several time as desired and may not rotated or moved see ¶0037, ¶0009, ¶0010, abstract), wherein the plurality of spikes create a series of perforations in the atherosclerotic plaque which allow a cleavage line to be formed in the atherosclerotic plaque while leaving most of a structure of the atherosclerotic plaque intact (the repeatedly inflating/ deflating the balloon will cut the plaque and most of the plaque will stay adhered to a wall of the vessel as spike will contact atherosclerotic plaque, ¶0037), wherein the series of microperforations assist stress release along the series of perforations to guide a fissure event (the series of the microperforations will help the fissure event in further inflation/ deflation ¶0037), but it fails to disclose that a height of the plurality of spikes is between 0.05 mm to 1.0 mm, wherein there is less likelihood of exposing or damaging the medical layer of the artery.
However, Grayzel discloses a balloon catheter (44, Fig. 2, Fig. 10b-10d) and wherein the balloon the plurality of spikes (projection 48) form tiny prick points in atherosclerotic plaque (¶0053, the projection can do cutting or piercing the occlusion/plaque) and a depth of penetration when actuated by inflation of the balloon to the low pressure (¶0011) and wherein the height of the plurality of spikes is between 0.05 mm to 1.0 mm, of 0.05 mm to 0.5 mm (wherein the height of the projection is vary see ¶0066, such as 0.004 inch (0.1mm) to 0.015 inches (0.38 mm) see ¶0058, wherein there is less likelihood of exposing or damaging the medical layer of the artery (piercing only the occlusion, ¶0077) and wherein the artery is only being prepared by the introduction of the plurality of spikes within the atherosclerotic plaque and an intended diameter of the vessel is larger than a fully expanded diameter of the balloon ( the height of the spike 48 and as used to pierce the occlusion within the lumen of the artery, ¶0059).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modified the spike of Melsheimer so that a height of the plurality of spikes is between 0.05 mm to 1.0 mm, wherein there is less likelihood of exposing or damaging the medical layer of the artery as taught by Grayzel for the purpose of utilizing a desired spike heights and specific spike’s shape for incising or piercing the plaque (Grayzel, ¶0058, ¶0015).
Re Claim 36, Melsheimer fails to disclose wherein inflating the balloon enables the atherosclerotic plaque to be dilated while avoiding forming random cracks that may lead to dissection.
However, Grayzel discloses a balloon catheter (44, Fig. 2, Fig. 10b-10d) and wherein the balloon the plurality of spikes (projection 48) form tiny prick points in atherosclerotic plaque (¶0053, the projection can do cutting or piercing the occlusion/plaque) and a depth of penetration when actuated by inflation of the balloon to the low pressure (¶0011) and wherein inflating the balloon to the low pressure enables the atherosclerotic plaque to be dilated while avoiding forming random cracks that may lead to dissection (piercing only the occlusion, ¶0077)
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modified the spike of Melsheimer so that inflating the balloon enables the atherosclerotic plaque to be dilated while avoiding forming random cracks that may lead to dissection as taught by Grayzel for the purpose of using a desired spike heights and specific shape for treating the plaque (Grayzel, ¶0058, ¶0077).
Re Claim 37, Melsheimer fails to disclose wherein a height of the plurality of spikes is not deep enough to cut through the thickness of the atherosclerotic plaque.
However, Grayzel discloses a balloon catheter (44, Fig. 2, Fig. 10b-10d) and wherein the balloon the plurality of spikes (projection 48) form tiny prick points in atherosclerotic plaque (¶0053, the projection can do cutting or piercing the occlusion/plaque) and a depth of penetration when actuated by inflation of the balloon to the low pressure (¶0011) and wherein a height of the plurality of spikes is not deep enough to cut through the thickness of the atherosclerotic plaque (piercing only the occlusion, ¶0077)
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modified the spike of Melsheimer so that a height of the plurality of spikes is not deep enough to cut through the thickness of the atherosclerotic plaque as taught by Grayzel for the purpose of using a desired spike heights and specific shape for treating the plaque (Grayzel, ¶0058, ¶0077).
Re Claim 38, Melsheimer fails to disclose wherein the series of perforations assist in generating a more uniform intraluminal surface roughness for vessel dilation compared with vessel dilation without inflating and deflating the balloon repeatedly to form atherosclerotic plaque with perforations.
However, Grayzel discloses a balloon catheter (44, Fig. 2, Fig. 10b-10d) and wherein the balloon the plurality of spikes (projection 48) form tiny prick points in atherosclerotic plaque wherein the series of perforations assist in generating a more uniform intraluminal surface roughness for vessel dilation compared with vessel dilation without inflating and deflating the balloon repeatedly to form atherosclerotic plaque with perforations (¶0053, the projection can do cutting or piercing the occlusion/plaque, compare with the same operation without cutting the plaque, ¶0077 such as crushing the occlusion) and a depth of penetration when actuated by inflation of the balloon to the low pressure (¶0011) and wherein a height of the plurality of spikes is not deep enough to cut through the thickness of the atherosclerotic plaque (piercing only the occlusion, ¶0077)
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modified the spike of Melsheimer so that the series of perforations assist in generating a more uniform intraluminal surface roughness for vessel dilation compared with vessel dilation without inflating and deflating the balloon repeatedly to form atherosclerotic plaque with perforations as taught by Grayzel for the purpose of using a desired spike heights and specific shape for treating the plaque (Grayzel, ¶0058, ¶0077).
Re Claim 39, Melsheimer fails to disclose wherein the series of perforations avoid high stress concentrations at an initial point of fracture for vessel dilation compared with vessel dilation without inflating and deflating the balloon repeatedly to form atherosclerotic plaque with perforations.
However, Grayzel discloses a balloon catheter (44, Fig. 2, Fig. 10b-10d) and wherein the balloon the plurality of spikes (projection 48) form tiny prick points in atherosclerotic plaque wherein the series of perforations assist in generating a more uniform intraluminal surface roughness for vessel dilation compared with vessel dilation without preparation of atherosclerotic plaque with perforations (¶0053, the projection can do cutting or piercing the occlusion/plaque, compare with the same operation without inflating and deflating the balloon repeatedly, ¶0077 such as crushing the occlusion) and a depth of penetration when actuated by inflation of the balloon to the low pressure (¶0011) and wherein a height of the plurality of spikes is not deep enough to cut through the thickness of the atherosclerotic plaque (piercing only the occlusion, ¶0077)
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modified the spike of Melsheimer so that the series of perforations avoid high stress concentrations at an initial point of fracture for vessel dilation compared with vessel dilation without inflating and deflating the balloon repeatedly to form atherosclerotic plaque with perforations as taught by Grayzel for the purpose of using a desired spike heights and specific shape for treating the plaque (Grayzel, ¶0058, ¶0077).
Re Claim 40, Melsheimer fails to disclose wherein the structure of the atherosclerotic plaque is left intact for more predictable compression characteristics of the atherosclerotic plaque compared with expansion characteristics of atherosclerotic plaque without perforations.
However, Grayzel discloses a balloon catheter (44, Fig. 2, Fig. 10b-10d) and wherein the balloon the plurality of spikes (projection 48) form tiny prick points in atherosclerotic plaque wherein the series of perforations assist in generating a more uniform intraluminal surface roughness for vessel dilation compared with vessel dilation without preparation of atherosclerotic plaque with perforations (¶0053, the projection can do cutting or piercing the occlusion/plaque, compare with the same operation without spikes, ¶0077 such as crushing the occlusion) and a depth of penetration when actuated by inflation of the balloon to the low pressure (¶0011) and wherein a height of the plurality of spikes is not deep enough to cut through the thickness of the atherosclerotic plaque (piercing only the occlusion, ¶0077)
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modified the spike of Melsheimer so that the structure of the atherosclerotic plaque is left intact for more predictable expansion characteristics of the atherosclerotic plaque compared with compression characteristics of atherosclerotic plaque without perforations as taught by Grayzel for the purpose of using a desired spike heights and specific shape for treating the plaque (Grayzel, ¶0058, ¶0077).
Claims 28, 30-33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Melsheimer in view of Grayzel and further in view of Wellman et al. (US. 20030065303A1) (“Wellman”).
Re Claim 28, Melsheimer discloses a method (balloon 14 of the catheter 10, Figs. 2-6) comprising: positioning a delivery device within a vessel (balloon 14 of the catheter 10, ¶0037, placed at the restriction/ plaque ¶0026), the delivery device comprising a plurality of spikes and a balloon (spikes 30 with base 32, body 34 and tip 35 and the balloon 14, Figs. 3-6, ¶0023, ¶0010), and inflating and deflating the balloon for a first time to move the plurality of spikes radially outward to engage atherosclerotic plaque and radially inward to disengage the atherosclerotic plaque (the balloon can be inflated and then deflated for the first time see ¶0037, ¶0009, ¶0010, abstract), without moving or rotating the delivery device, inflating and deflating the balloon for a second time to move the plurality of spikes radially outward to engage atherosclerotic plaque and radially inward to disengage the atherosclerotic plaque (¶0037, the balloon can be inflated several time and may not need to be rotated or moved, inflating the balloon for the second time, ¶0006), without moving or rotating the delivery device, inflating and deflating the balloon for a third time to move the plurality of spikes radially outward to engage atherosclerotic plaque and radially inward to disengage the atherosclerotic plaque (¶0037, the balloon can be inflated several time and may not need to be rotated or moved, inflating the balloon the third time, ¶0006), without moving or rotating the delivery device, inflating and deflating the balloon for a fourth time to move the plurality of spikes radially outward to engage atherosclerotic plaque and radially inward to disengage the atherosclerotic plaque (¶0037, the balloon can be inflated several time and may not need to be rotated or moved, inflating the balloon for the fourth time, ¶0006), wherein the plurality of spikes form perforations in atherosclerotic plaque with a shallow depth of penetration when actuated by inflation of the balloon while leaving most of a surface of the atherosclerotic plaque adherent to the wall of the vessel (the spike are used to cut the plaque, so most of the plaque will stay adhered to a wall of the vessel, ¶0037), but it fails to disclose that a distance between the perforations is in the range of 0.01 mm to 2 mm, wherein the distance between the perforations is equal to or greater than a depth of the plurality of spikes, wherein there is less likelihood of a dissection occurring deeply and exposing the media layer of the vessel, wherein inflating the balloon promotes uniform expansion of the atherosclerotic plaque during angioplasty compared with expansion of atherosclerotic plaque without perforation.
However, Grayzel discloses a balloon catheter (44, Fig. 2, Fig. 10b-10d) and wherein the balloon the plurality of spikes (projection 48) form tiny prick points in atherosclerotic plaque (¶0053, the projections are performing cutting or piercing to the occlusion/plaque) and wherein the distance between the perforations is equal to or greater than a depth of the plurality of spikes a depth of penetration (¶0011, the perforations have distance between a row of spikes 48 and next row of spikes 48, Fig. 2, and a longitudinal distance between two spiks in the same, the distances can be ¶0080, so the distance between the longitudinal perforations as in Fig. 2 are more than the depth of the spike) and wherein there is less likelihood of a dissection occurring deeply and exposing the media layer of the vessel ( as the projection/spike 48 have same height of the current application and it used only for piercing the occlusion see ¶0058- ¶0059, it is less likelihood of a dissection occurring deeply and exposing the media layer of the vessel as the spikes are piercing the plaque, ¶0054), wherein inflating the balloon promotes uniform expansion of the atherosclerotic plaque during angioplasty compared with expansion of atherosclerotic plaque without perforation (¶0015, ¶0077, as the spike is uniformly distributed around the balloon, the spike will pierce the plaque uniformly and will promotes uniform expansion of the atherosclerotic plaque during angioplasty compared to expansion of atherosclerotic plaque with balloon without spikes).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modified the spike of Melsheimer so that the distance between the perforations is equal to or greater than a depth of the plurality of spikes, wherein there is less likelihood of a dissection occurring deeply and exposing the media layer of the vessel, wherein inflating the balloon promotes uniform expansion of the atherosclerotic plaque during angioplasty compared with expansion of atherosclerotic plaque without perforation as taught by Grayzel for the purpose of utilizing a desired spike heights and specific spike’s shape for incising or piercing the plaque (Grayzel, ¶0058, ¶0015).
Also, Melsheimer in view of Grayzel is silent as to the specifics of a distance between the perforations is in the range of 0.01 mm to 2 mm.
However, Wellman discloses a balloon catheter ( Fig. 1-3) and wherein a distance between the perforations is in the range of 0.01 mm to 2 mm (the distance between the perforations can be vary see ¶0030-¶0031 such as 250 micron = 0.25mm in Fig. 2b).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modified the spike of Melsheimer so that a distance between the perforations is in the range of 0.01 mm to 2 mm as taught by Wellman for the purpose of utilizing a desired spike density to treat the diseased coronary arteries (Wellman, ¶0030-¶0031).
Re Claim 30, the modified Melsheimer discloses wherein the vessel is subsequently enlarged to a size consistent with an original diameter of the vessel (wherein the vessel is subsequently enlarged to a size consistent with an original diameter of the vessel as the balloon inflated will press on the plaque so the size of vessel subsequently enlarged ¶0032 of Melsheimer).
Re Claim 31, the modified Melsheimer discloses wherein inflating the balloon creates less plaque dissection for vessel dilatation compared with vessel dilatation without inflating and deflating the balloon four times to form atherosclerotic plaque with perforations (the modified Melsheimer will form the tiny prick points see ¶0010 of Melsheimer, the inflating/deflating the balloon with spikes will create less plaque dissection for vessel dilatation compared to a high pressurized inflated dilation balloon with spike, see also Grayzel, Fig. 2, ¶0011).
Re Claim 32, the modified Melsheimer discloses wherein inflating the balloon leads to less residual stenosis for vessel dilatation compared with vessel dilatation without inflating and deflating the balloon four times to form atherosclerotic plaque with perforations (the modified Melsheimer will form the tiny prick points see ¶0010 of Melsheimer, the inflating/deflating the balloon with spikes will create less residual stenosis for vessel dilatation compared to a high pressurized inflated dilation balloon with spike, see also Grayzel, Fig. 2, ¶0011).
Re Claim 33, the modified Melsheimer discloses wherein inflating the balloon creates less injury to the intima and media in the vessel for vessel dilatation compared with vessel dilatation without inflating and deflating the balloon four times to form atherosclerotic plaque with perforations (the modified Melsheimer will form the tiny prick points see ¶0010 of Melsheimer, the inflating/deflating the balloon with spikes will create less injury to the intima and media in the vessel compared to a high pressurized inflated dilation balloon which is a balloon with spike, see also Grayzel, Fig. 2, ¶0011).
Response to Arguments
Applicant’s arguments filed on 8/4/2025 with respect to claim(s) 21, 28, 34 and newly added “ inflating/ deflating ..”and with regards Melsheimer and Grayzel have been considered but are not persuasive as Melsheimer in ¶0037 discloses a repeated inflating/ deflating the balloon multiple times without a need to rotate or move the balloon as ¶0037 uses the term “may rotate” means may or may not.
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783