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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 8-9, 11-15, 17-18, 20-23 is/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.
Claim 1 recites, “the one or more primary spines comprising a plurality of primary radial openings therethrough” and it is not clear if, in the case where there are multiple primary spines, whether the case of “a plurality of primary radial openings therethrough” would apply to one primary spine or all primary spines (i.e., if in the case where multiple primary spines are included, whether one primary spine may have one primary opening and other primary spines may have multiple primary openings, etc.). The claim language does not sufficiently define the number of primary radial openings present on each of the included primary spines and is thus indefinite. Examiner suggests that the claim be amended to recite, “the one or more primary spines each comprising a plurality of primary radial openings therethrough” to overcome the currently presented indefinite language.
Claim 1 additionally recites, “the one or more secondary spines comprising one or more secondary openings therethrough” and it is not clear if, in the case where there are multiple secondary spines, whether the case of “one or more secondary openings therethrough” would apply to one secondary spine or all secondary spines (i.e., if in the case where multiple secondary spines are included, whether one secondary spine may have one secondary opening and other secondary spines may have multiple secondary openings, etc.). The claim language does not sufficiently define the number of secondary openings present on each of the included secondary spines and is thus indefinite. Examiner suggests that the claim be amended to recite, “the one or more secondary spines each comprising one or more secondary openings therethrough” to overcome the currently presented indefinite language.
Claims 2-6, 8-9 and 11 are also rendered indefinite due to their dependency from and further modification of claim 1.
Claim 8 recites, “wherein at least two of the one or more secondary openings in one of the secondary spines” which is indefinite as “at least two” secondary openings are not required to be present along the secondary spine. As claim 1 recites, “the one or more secondary spines comprising one or more secondary openings therethrough”, only one secondary opening may be present along the one or more secondary spines to meet the required limitations of the base claim.
Claim 9 is additionally rendered indefinite due to its dependency from and further modification of claim 8.
Claim 12 recites, “the one or more primary spines comprising a plurality of primary radial openings therethrough” and it is not clear if, in the case where there are multiple primary spines, whether the case of “a plurality of primary radial openings therethrough” would apply to one primary spine or all primary spines (i.e., if in the case where multiple primary spines are included, whether one primary spine may have one primary opening and other primary spines may have multiple primary openings, etc.). The claim language does not sufficiently define the number of primary radial openings present on each of the included primary spines and is thus indefinite. Examiner suggests that the claim be amended to recite, “the one or more primary spines each comprising a plurality of primary radial openings therethrough” to overcome the currently presented indefinite language.
Claim 12 additionally recites, “the one or more secondary spines comprising one or more secondary openings therethrough” and it is not clear if, in the case where there are multiple secondary spines, whether the case of “one or more secondary openings therethrough” would apply to one secondary spine or all secondary spines (i.e., if in the case where multiple secondary spines are included, whether one secondary spine may have one secondary opening and other secondary spines may have multiple secondary openings, etc.). The claim language does not sufficiently define the number of secondary openings present on each of the included secondary spines and is thus indefinite. Examiner suggests that the claim be amended to recite, “the one or more secondary spines each comprising one or more secondary openings therethrough” to overcome the currently presented indefinite language.
Claims 13-15, 17-19 and 20 are also rendered indefinite due to their dependency from and further modification of claim 12.
Claim 14 recites, “wherein at least two of the one or more secondary openings in one of the secondary spines” which is indefinite as “at least two” secondary openings are not required to be present along the secondary spine. As claim 12 recites, “the one or more secondary spines comprising one or more secondary openings therethrough”, only one secondary opening may be present along the one or more secondary spines to meet the required limitations of the base claim.
Claim 15 is additionally rendered indefinite due to its dependency from and further modification of claim 14.
Claim 21 recites, “the one or more primary spines comprising a plurality of primary radial openings therethrough” and it is not clear if, in the case where there are multiple primary spines, whether the case of “a plurality of primary radial openings therethrough” would apply to one primary spine or all primary spines (i.e., if in the case where multiple primary spines are included, whether one primary spine may have one primary opening and other primary spines may have multiple primary openings, etc.). The claim language does not sufficiently define the number of primary radial openings present on each of the included primary spines and is thus indefinite. Examiner suggests that the claim be amended to recite, “the one or more primary spines each comprising a plurality of primary radial openings therethrough” to overcome the currently presented indefinite language.
Claim 21 additionally recites, “the one or more secondary spines comprising one or more secondary openings therethrough” and it is not clear if, in the case where there are multiple secondary spines, whether the case of “one or more secondary openings therethrough” would apply to one secondary spine or all secondary spines (i.e., if in the case where multiple secondary spines are included, whether one secondary spine may have one secondary opening and other secondary spines may have multiple secondary openings, etc.). The claim language does not sufficiently define the number of secondary openings present on each of the included secondary spines and is thus indefinite. Examiner suggests that the claim be amended to recite, “the one or more secondary spines each comprising one or more secondary openings therethrough” to overcome the currently presented indefinite language.
Claim 21 additionally recites, “wherein at least two of the one or more secondary openings in one of the secondary spines” which is indefinite as “at least two” secondary openings are not required to be present along the secondary spine. As preceding limitations of claim 21 recite, “the one or more secondary spines comprising one or more secondary openings therethrough”, only one secondary opening may be present along the one or more secondary spines to meet the required limitations of the base claim.
Claims 22-23 are additionally rendered indefinite due to their dependency from and further modification of claim 21.
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) 1-6, 8-9, 11-15, 17-18 and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burke (US 2010/0168714 A1) in view of Orth (WO 2021133966 A1).
Regarding claim 1, Burke discloses:
An intravascular apparatus adapted for delivery of fluid (see Fig. 5), comprising:
an inflatable balloon (expandable portion 14; see Fig. 5) having an inflated cylindrical configuration (see Fig. 5; see also Para. [0018] and [0041]); and
an expandable infusion scaffold comprising one or more primary spines (primary conduits 20; see Fig. 5; see also Para(s). [0043]-[0044] and [0047]) and one or more secondary spines (secondary conduits 30; see Fig. 5; see also Para. [0047]) disposed about an outer cylindrical surface of the inflatable balloon (see Fig. 5; see also Para. [0043]-[0044] and [0047]);
wherein the one or more primary spines comprising a plurality of primary radial openings therethrough (primary delivery ports 24a-24b; see Fig. 5; see also Para. [0048]) configured to facilitate delivery of a primary agent therefrom (see Para. [0044] and [0047]-[0048]);
wherein the one or more secondary spines comprising one or more secondary openings therethrough (secondary delivery ports 34a-34b; see Fig. 5; see also Para. [0048]) that are not associated with a needle and are not adapted to deploy a needle therefrom (see Para. [0044] and [0047]-[0048]; secondary conduits 30 not disclosed to house or deploy needles therefrom), and wherein the one or more secondary openings are in communication with a secondary spine lumen to facilitate delivery of a secondary agent from a proximal end of the apparatus, through the secondary spine lumen, and out of the one or more secondary openings (see Para. [0044] and [0047]-[0048]).
However, Burke does not expressly disclose:
Wherein the plurality of primary radial openings of the one or more primary spines are associated with a needle that has a delivery configuration within a primary spine lumen of the primary spine in which a distal tip of the needle is radially constrained by the primary spine, and a deployed configuration in which the needle extends radially outward from the associated primary radial opening after the needle is moved axially relative to the primary spine to facilitate delivery of a primary agent from the needle; and
wherein the one or more secondary spines have a smaller outer diameter ("OD") than the one or more primary spines.
In the same field of endeavor, namely inflatable intravascular therapeutic agent delivery devices, Orth teaches:
An intravascular apparatus adapted for delivery of fluid (see Fig. 1), comprising:
an inflatable balloon (inflatable member 150; see Fig. 1) having an inflated cylindrical configuration (see Fig. 1; see also Para. [0108]); and
an expandable infusion scaffold (infusion scaffold 110; see Fig. 1) comprising one or more primary spines (infusion spines 112a-112c; see Fig. 1; see also Para. [0108]) disposed about an outer cylindrical surface of the inflatable balloon (see Fig. 1; see also Para. [0108]);
wherein the one or more primary spines comprising a plurality of primary radial openings therethrough (see Para. [0117]), each of the plurality of primary radial openings associated with a needle (needles 114a-114c; see Fig. 1; see also Para. [0117]) that has a delivery configuration within a primary spine lumen of the primary spine in which a distal tip of the needle is radially constrained by the primary spine, and a deployed configuration in which the needle extends radially outward from the associated primary radial opening after the needle is moved axially relative to the primary spine (see Figs. 1 and 5; see also Para. [0009] and [0117]; needles 114a-114c radially constrained within lumen(s) of respective infusion spines 112a-112c until actuated to extend radially outward therefrom) to facilitate delivery of a primary agent from the needle (see Para. [0078] and [0105]);
wherein the plurality of selectively deployable needles associated with the plurality of radial openings of the primary spine allow for more targeted, uniform circumferential coverage and a greater span of tissue along the lesion length to be targeted with the agent without having to move the infusion device within the vessel (see Para. [0104]);
wherein the selectively deployable needles associated with the plurality of radial openings of the primary spine additionally allow a user to optionally pierce the needles through the vessel wall so as to enter the adventitia layer of the vessel wall to deliver a desired therapeutic agent though the needles, out of the needles, and into the target tissue within the vessel wall (see Para. [0105]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the primary conduits of Burke to comprise a plurality of selectively-deployable needles therein configured to deliver therapeutic material to a target location as taught and suggested by Orth to, in this case, allow the primary conduits of Burke, via incorporation of the deployable therapeutic needles therein, to provide more targeted, uniform circumferential coverage in deploying therapeutic material along a greater span of tissue along a lesion length without having to move the infusion device within the vessel (see Orth Para. [0104]). The selectively deployable needles would further allow a user to optionally pierce the deployable therapeutic needles through the vessel wall so as to enter the adventitia layer of the vessel wall to deliver a desired therapeutic agent though the needles, out of the needles, and into the target tissue within the vessel wall (see Orth Para. [0105]).
Regarding the limitations of, “wherein the one or more secondary spines have a smaller outer diameter ("OD") than the one or more primary spines”, since Burke does not provide express disclosure pertaining to the relative dimensions of the primary conduits and secondary conduits, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the outer diameter of the secondary conduits of Burke et al. to have an outer diameter smaller than that of the primary conduits since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Burke et al. would not operate differently with the claimed relative outer diameter dimensions since Burke provides no disclosure pertaining to the relative dimensions of the primary conduits and secondary conduits. This indicates that one of ordinary skill in the art would be permitted to modify the relative dimensions of the primary conduit(s) and secondary conduit(s) without hindering or infringing upon any beneficial operational function inherent to the currently disclosed relative dimensions. Further, applicant places no criticality on claimed relative dimensions, indicating simply that the outer diameter of the secondary spines may “optionally” be smaller than the one or more primary spines (see Specification Para. [0013] and [0181]). Examiner notes that while Para. [0181] of the specification mentions wherein smaller-diameter spines may help reduce the overall diameter profile of the device, this is seen to be an inherent feature of minimizing dimensions and does not provide an express or unique benefit aiding in the operational function of the device. Further this disclosure appears to pertain to dimensions (I.e., in general) rather than the specific relative dimensions presented in the claims.
Regarding claim 2, the combination of Burke and Orth disclose all the limitations of the invention of claim 1.
However, none of either Burke or Orth expressly disclose wherein the one or more secondary spines have an OD not more than 50% of an OD of the one or more primary spines.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the outer diameter of the secondary conduits of Burke et al. to have an outer diameter of not more than 50% that of the primary conduits since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Burke et al. would not operate differently with the claimed relative outer diameter dimensions since Burke provides no disclosure pertaining to the relative dimensions of the primary conduits and secondary conduits. This indicates that one of ordinary skill in the art would be permitted to modify the relative dimensions of the primary conduit(s) and secondary conduit(s) without hindering or infringing upon any beneficial operational function inherent to the currently disclosed relative dimensions. Further, applicant places no criticality on claimed relative dimensions, indicating simply that the outer diameter of the secondary spines may “optionally” be not more than 50% of an outer diameter of one or more primary spines (see Specification Para. [0013]) without disclosing or suggesting any beneficial operational function pertaining to the claimed relative dimensions.
Regarding claim 3, the combination of Burke and Orth disclose all the limitations of the invention of claim 1.
However, none of either Burke or Orth expressly disclose wherein the one or more secondary spines have an OD not more than 25% of an OD of the one or more primary spines.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the outer diameter of the secondary conduits of Burke et al. to have an outer diameter of not more than 25% that of the primary conduits since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Burke et al. would not operate differently with the claimed relative outer diameter dimensions since Burke provides no disclosure pertaining to the relative dimensions of the primary conduits and secondary conduits. This indicates that one of ordinary skill in the art would be permitted to modify the relative dimensions of the primary conduit(s) and secondary conduit(s) without hindering or infringing upon any beneficial operational function inherent to the currently disclosed relative dimensions. Further, applicant places no criticality on claimed relative dimensions, indicating simply that the outer diameter of the secondary spines may “optionally” be not more than 25% of an outer diameter of one or more primary spines (see Specification Para. [0013]) without disclosing or suggesting any beneficial operational function pertaining to the claimed relative dimensions.
Regarding claim 4, the combination of Burke and Orth disclose the invention of claim 1, Burke further discloses wherein the one or more secondary spines are equidistant from first and second circumferentially closest primary spines (see Para. [0054]; conduits may be spaced apart from one another at equal distances).
Regarding claim 5, the combination of Burke and Orth disclose the invention of claim 1, Burke further discloses wherein the one or more secondary spines are not equidistant from first and second circumferentially closest primary spines (see Para. [0054]; conduits may be spaced apart from one-another at non-equal distance).
Regarding claim 6, the combination of Burke and Orth disclose the invention of claim 5, Burke further discloses wherein longitudinal axes of the one or more secondary spines are circumferentially offset from a longitudinal axis of a circumferentially closest primary spine between 0-350 degrees, wherein the angle is defined by lines each passing through a long axis of the apparatus and the associated long axis of the related spine (see Para. [0054]; conduits are spaced apart from one another at equal distances around the circumference of the expandable portion 14; Fig. 5 shows two secondary conduits 30 (other secondary conduit on back-side, not shown, per Para. [0044]) and two adjacent primary conduits 20; at equidistant spacing, adjacent conduits are spaced apart from one-another within the range of between 0-350 degrees (i.e., 360/4=90 degrees of separation)).
Regarding claim 8 (see 112(b) rejection above), the combination of Burke and Orth disclose the invention of claim 1, Burke further discloses wherein at least two of the one or more secondary openings in one of the secondary spines are axially spaced (see Fig. 5) and do not have the same size (see Para. [0048]).
Regarding claim 9, the combination of Burke and Orth disclose the invention of claim 8, Burke further discloses wherein a distal secondary opening is larger than a proximal secondary opening (see Para. [0048]; secondary distal delivery port 34a may be larger than secondary proximal delivery port 34b), and the secondary openings are sized, positioned and configured to enhance the distribution of flow out of the two or more secondary openings (see Para. [0048]; as claims do not expand upon the conditions through which this functional limitation is met, the different relative sizes of the secondary openings previously recited are understood to provide the functional benefit).
Regarding claim 11, the combination of Burke and Orth disclose the invention of claim 1, Burke further discloses wherein longitudinal axes of the one or more secondary spines are circumferentially offset from a longitudinal axis of a circumferentially closest primary spine between 0-350 degrees, wherein the angle is defined by lines each passing through a long axis of the apparatus and the associated long axis of the related spine (see Para. [0054]; conduits are spaced apart from one another at equal distances around the circumference of the expandable portion 14; Fig. 5 shows two secondary conduits 30 (other secondary conduit on back-side, not shown, per Para. [0044]) and two adjacent primary conduits 20; at equidistant spacing, adjacent conduits are spaced apart from one-another within the range of between 0-350 degrees (i.e., 360/4=90 degrees of separation)).
Regarding claim 12, Burke discloses:
An intravascular apparatus adapted for delivery of fluid (see Fig. 5), comprising:
an inflatable balloon (expandable portion 14; see Fig. 5) having an inflated cylindrical configuration (see Fig. 5; see also Para. [0018] and [0041]); and
an expandable infusion scaffold comprising one or more primary spines (primary conduits 20; see Fig. 5; see also Para(s). [0043]-[0044] and [0047]) and one or more secondary spines (secondary conduits 30; see Fig. 5; see also Para. [0047]) disposed about an outer cylindrical surface of the inflatable balloon (see Fig. 5; see also Para. [0043]-[0044] and [0047]);
wherein the one or more primary spines comprising a plurality of primary radial openings therethrough (primary delivery ports 24a-24b; see Fig. 5; see also Para. [0048]) configured to facilitate delivery of a primary agent therefrom (see Para. [0044] and [0047]-[0048]);
wherein the one or more secondary spines comprising one or more secondary openings therethrough (secondary delivery ports 34a-34b; see Fig. 5; see also Para. [0048]) that are not associated with a needle and are not adapted to deploy a needle therefrom (see Para. [0044] and [0047]-[0048]; secondary conduits 30 not disclosed to house or deploy needles therefrom), and wherein the one or more secondary openings are in communication with a secondary spine lumen to facilitate delivery of a secondary agent from a proximal end of the apparatus, through the secondary spine lumen, and out of the one or more secondary openings (see Para. [0044] and [0047]-[0048]);
wherein longitudinal axes of the one or more secondary spines are circumferentially offset from a longitudinal axis of a circumferentially closest primary spine between 0-350 degrees (see Para. [0054]; conduits are spaced apart from one another at equal distances around the circumference of the expandable portion 14; Fig. 5 shows two secondary conduits 30 (other secondary conduit on back-side, not shown, per Para. [0044]) and two adjacent primary conduits 20; at equidistant spacing, adjacent conduits are spaced apart from one-another within the range of between 0-350 degrees (i.e., 360/4=90 degrees of separation)).
However, Burke does not expressly disclose:
Wherein the plurality of primary radial openings of the one or more primary spines are associated with a needle that has a delivery configuration within a primary spine lumen of the primary spine in which a distal tip of the needle is radially constrained by the primary spine, and a deployed configuration in which the needle extends radially outward from the associated primary radial opening after the needle is moved axially relative to the primary spine to facilitate delivery of a primary agent from the needle.
In the same field of endeavor, namely inflatable intravascular therapeutic agent delivery devices, Orth teaches:
An intravascular apparatus adapted for delivery of fluid (see Fig. 1), comprising:
an inflatable balloon (inflatable member 150; see Fig. 1) having an inflated cylindrical configuration (see Fig. 1; see also Para. [0108]); and
an expandable infusion scaffold (infusion scaffold 110; see Fig. 1) comprising one or more primary spines (infusion spines 112a-112c; see Fig. 1; see also Para. [0108]) disposed about an outer cylindrical surface of the inflatable balloon (see Fig. 1; see also Para. [0108]);
wherein the one or more primary spines comprising a plurality of primary radial openings therethrough (see Para. [0117]), each of the plurality of primary radial openings associated with a needle (needles 114a-114c; see Fig. 1; see also Para. [0117]) that has a delivery configuration within a primary spine lumen of the primary spine in which a distal tip of the needle is radially constrained by the primary spine, and a deployed configuration in which the needle extends radially outward from the associated primary radial opening after the needle is moved axially relative to the primary spine (see Figs. 1 and 5; see also Para. [0009] and [0117]; needles 114a-114c radially constrained within lumen(s) of respective infusion spines 112a-112c until actuated to extend radially outward therefrom) to facilitate delivery of a primary agent from the needle (see Para. [0078] and [0105]);
wherein the plurality of selectively deployable needles associated with the plurality of radial openings of the primary spine allow for more targeted, uniform circumferential coverage and a greater span of tissue along the lesion length to be targeted with the agent without having to move the infusion device within the vessel (see Para. [0104]);
wherein the selectively deployable needles associated with the plurality of radial openings of the primary spine additionally allow a user to optionally pierce the needles through the vessel wall so as to enter the adventitia layer of the vessel wall to deliver a desired therapeutic agent though the needles, out of the needles, and into the target tissue within the vessel wall (see Para. [0105]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the primary conduits of Burke to comprise a plurality of selectively-deployable needles therein configured to deliver therapeutic material to a target location as taught and suggested by Orth to, in this case, allow the primary conduits of Burke, via incorporation of the deployable therapeutic needles therein, to provide more targeted, uniform circumferential coverage in deploying therapeutic material along a greater span of tissue along a lesion length without having to move the infusion device within the vessel (see Orth Para. [0104]). The selectively deployable needles would further allow a user to optionally pierce the deployable therapeutic needles through the vessel wall so as to enter the adventitia layer of the vessel wall to deliver a desired therapeutic agent though the needles, out of the needles, and into the target tissue within the vessel wall (see Orth Para. [0105]).
Regarding claim 13, the combination of Burke and Orth disclose all of the limitations of the invention of claim 12.
However, Burke does not expressly disclose wherein longitudinal axes of the one or more secondary spines are circumferentially offset from the longitudinal axis of the circumferentially closest primary spine between 00-250.
Burke provides disclosure (see Para. [0054]) that the distances between each adjacent conduit along the surface of the expandable portion 14 needs to be optimized so as to be equidistant to “produce better local distribution of the therapeutic agent along the entire treatment site.” As Burke discloses wherein any number of conduits may be included along the surface of the expandable portion 14 (see Para. [0054]), the spacing between each conduit is disclosed to be a result effective variable in that changing the number of conduits along the outer surface of the expandable portion changes the degree of separation between each conduit which affects the distribution pattern of the therapeutic agent along the treatment site. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Burke et al. by changing the spacing between adjacent conduits to be between 0-25 degrees (i.e., in a case where 18 or more conduits are present) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14 (see 112(b) rejection above), the combination of Burke and Orth disclose the invention of claim 12, Burke further discloses wherein at least two of the one or more secondary openings in one of the secondary spines are axially spaced (see Fig. 5) and do not have the same size (see Para. [0048]).
Regarding claim 15, the combination of Burke and Orth disclose the invention of claim 14, Burke further discloses wherein a distal secondary opening is larger than a proximal secondary opening (see Para. [0048]; secondary distal delivery port 34a may be larger than secondary proximal delivery port 34b), and the secondary openings are sized, positioned and configured to enhance the distribution of flow out of the two or more secondary openings (see Para. [0048]; as claims do not expand upon the conditions through which this functional limitation is met, the different relative sizes of the secondary openings previously recited are understood to provide the functional benefit).
Regarding claim 17, the combination of Burke and Orth disclose all the limitations of the invention of claim 12.
However, Burke does not expressly disclose wherein the one or more secondary spines have a smaller outer diameter ("OD") than the one or more primary spines.
Since Burke does not provide express disclosure pertaining to the relative dimensions of the primary conduits and secondary conduits, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the outer diameter of the secondary conduits of Burke et al. to have an outer diameter smaller than that of the primary conduits since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Burke et al. would not operate differently with the claimed relative outer diameter dimensions since Burke provides no disclosure pertaining to the relative dimensions of the primary conduits and secondary conduits. This indicates that one of ordinary skill in the art would be permitted to modify the relative dimensions of the primary conduit(s) and secondary conduit(s) without hindering or infringing upon any beneficial operational function inherent to the currently disclosed relative dimensions. Further, applicant places no criticality on claimed relative dimensions, indicating simply that the outer diameter of the secondary spines may “optionally” be smaller than the one or more primary spines (see Specification Para. [0013] and [0181]). Examiner notes that while Para. [0181] of the specification mentions wherein smaller-diameter spines may help reduce the overall diameter profile of the device, this is seen to be an inherent feature of minimizing dimensions and does not provide an express or unique benefit aiding in the operational function of the device. Further this disclosure appears to pertain to dimensions (I.e., in general) rather than the specific relative dimensions presented in the claims.
Regarding claim 18, the combination of Burke and Orth disclose all the limitations of the invention of claim 17.
However, none of either Burke or Orth expressly disclose wherein the one or more secondary spines have an OD not more than 50% of an OD of the one or more primary spines.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the outer diameter of the secondary conduits of Burke et al. to have an outer diameter of not more than 50% that of the primary conduits since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Burke et al. would not operate differently with the claimed relative outer diameter dimensions since Burke provides no disclosure pertaining to the relative dimensions of the primary conduits and secondary conduits. This indicates that one of ordinary skill in the art would be permitted to modify the relative dimensions of the primary conduit(s) and secondary conduit(s) without hindering or infringing upon any beneficial operational function inherent to the currently disclosed relative dimensions. Further, applicant places no criticality on claimed relative dimensions, indicating simply that the outer diameter of the secondary spines may “optionally” be not more than 50% of an outer diameter of one or more primary spines (see Specification Para. [0013]) without disclosing or suggesting any beneficial operational function pertaining to the claimed relative dimensions.
Regarding claim 20, the combination of Burke and Orth disclose the invention of claim 12, Burke further discloses wherein the one or more secondary spines are not equidistant from first and second circumferentially closest primary spines (see Para. [0054]; conduits may be spaced apart from one-another at non-equal distance).
Regarding claim 21 (see 112(b) rejection above), Burke discloses:
An intravascular apparatus adapted for delivery of fluid (see Fig. 5), comprising:
an inflatable balloon (expandable portion 14; see Fig. 5) having an inflated cylindrical configuration (see Fig. 5; see also Para. [0018] and [0041]); and
an expandable infusion scaffold comprising one or more primary spines (primary conduits 20; see Fig. 5; see also Para(s). [0043]-[0044] and [0047]) and one or more secondary spines (secondary conduits 30; see Fig. 5; see also Para. [0047]) disposed about an outer cylindrical surface of the inflatable balloon (see Fig. 5; see also Para. [0043]-[0044] and [0047]);
wherein the one or more primary spines comprising a plurality of primary radial openings therethrough (primary delivery ports 24a-24b; see Fig. 5; see also Para. [0048]) configured to facilitate delivery of a primary agent therefrom (see Para. [0044] and [0047]-[0048]);
wherein the one or more secondary spines comprising one or more secondary openings therethrough (secondary delivery ports 34a-34b; see Fig. 5; see also Para. [0048]) that are not associated with a needle and are not adapted to deploy a needle therefrom (see Para. [0044] and [0047]-[0048]; secondary conduits 30 not disclosed to house or deploy needles therefrom), and wherein the one or more secondary openings are in communication with a secondary spine lumen to facilitate delivery of a secondary agent from a proximal end of the apparatus, through the secondary spine lumen, and out of the one or more secondary openings (see Para. [0044] and [0047]-[0048]).
wherein at least two of the one or more secondary openings in one of the secondary spines are axially spaced (see Fig. 5) and do not have the same size (see Para. [0048]).
However, Burke does not expressly disclose:
Wherein the plurality of primary radial openings of the one or more primary spines are associated with a needle that has a delivery configuration within a primary spine lumen of the primary spine in which a distal tip of the needle is radially constrained by the primary spine, and a deployed configuration in which the needle extends radially outward from the associated primary radial opening after the needle is moved axially relative to the primary spine to facilitate delivery of a primary agent from the needle.
In the same field of endeavor, namely inflatable intravascular therapeutic agent delivery devices, Orth teaches:
An intravascular apparatus adapted for delivery of fluid (see Fig. 1), comprising:
an inflatable balloon (inflatable member 150; see Fig. 1) having an inflated cylindrical configuration (see Fig. 1; see also Para. [0108]); and
an expandable infusion scaffold (infusion scaffold 110; see Fig. 1) comprising one or more primary spines (infusion spines 112a-112c; see Fig. 1; see also Para. [0108]) disposed about an outer cylindrical surface of the inflatable balloon (see Fig. 1; see also Para. [0108]);
wherein the one or more primary spines comprising a plurality of primary radial openings therethrough (see Para. [0117]), each of the plurality of primary radial openings associated with a needle (needles 114a-114c; see Fig. 1; see also Para. [0117]) that has a delivery configuration within a primary spine lumen of the primary spine in which a distal tip of the needle is radially constrained by the primary spine, and a deployed configuration in which the needle extends radially outward from the associated primary radial opening after the needle is moved axially relative to the primary spine (see Figs. 1 and 5; see also Para. [0009] and [0117]; needles 114a-114c radially constrained within lumen(s) of respective infusion spines 112a-112c until actuated to extend radially outward therefrom) to facilitate delivery of a primary agent from the needle (see Para. [0078] and [0105]);
wherein the plurality of selectively deployable needles associated with the plurality of radial openings of the primary spine allow for more targeted, uniform circumferential coverage and a greater span of tissue along the lesion length to be targeted with the agent without having to move the infusion device within the vessel (see Para. [0104]);
wherein the selectively deployable needles associated with the plurality of radial openings of the primary spine additionally allow a user to optionally pierce the needles through the vessel wall so as to enter the adventitia layer of the vessel wall to deliver a desired therapeutic agent though the needles, out of the needles, and into the target tissue within the vessel wall (see Para. [0105]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the primary conduits of Burke to comprise a plurality of selectively-deployable needles therein configured to deliver therapeutic material to a target location as taught and suggested by Orth to, in this case, allow the primary conduits of Burke, via incorporation of the deployable therapeutic needles therein, to provide more targeted, uniform circumferential coverage in deploying therapeutic material along a greater span of tissue along a lesion length without having to move the infusion device within the vessel (see Orth Para. [0104]). The selectively deployable needles would further allow a user to optionally pierce the deployable therapeutic needles through the vessel wall so as to enter the adventitia layer of the vessel wall to deliver a desired therapeutic agent though the needles, out of the needles, and into the target tissue within the vessel wall (see Orth Para. [0105]).
Regarding claim 22, the combination of Burke and Orth disclose the invention of claim 21, Burke further discloses wherein a distal secondary opening is larger than a proximal secondary opening (see Para. [0048]; secondary distal delivery port 34a may be larger than secondary proximal delivery port 34b), and the secondary openings are sized, positioned and configured to enhance the distribution of flow out of the two or more secondary openings (see Para. [0048]; as claims do not expand upon the conditions through which this functional limitation is met, the different relative sizes of the secondary openings previously recited are understood to provide the functional benefit).
Regarding claim 23, the combination of Burke and Orth disclose the invention of claim 22, Burke further discloses wherein the secondary openings have a continuously increasing size from a proximal-most secondary opening to a distal-most secondary opening (see Para. [0048]; secondary distal delivery port 34a may be larger than secondary proximal delivery port 34b; size therefore increases continuously from the proximal secondary delivery port to the distal secondary delivery port).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s
disclosure. See the attached PTO-892 Notice of Reference Cited. Specifically, US 8357118 B2 to Orr, US 2010/0069837 A1 to Rassat, US 2022/0265292 A1 to Carpenter, US 2013/0237909 A1 to Orr, US 2016/0243333 A1 to Seward, US 7837670 B2 to Barath and US 10350392 B2 to Fischell all disclose balloon catheter devices comprising needles extending through lumens along the surface of a balloon configured to deliver therapeutic material to a target site.
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/M.B.H./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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