DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 40 is objected to because of the following informalities:
The phrase “the curve of the first guide tube, the second guide tube, and the third guide tube” on lines 7-8 lacks proper antecedent basis since this is the first time that such a “curve” is being introduced in claim (note that the term “curve” on line 5 is a verb, not a subject). Additionally, this language is grammatically incorrect because it sets forth that a single “curve” belongs to all three guide tubes. It is suggested to amend lines 7-9 to recite “wherein [[the]] a curve of each of the first guide tube, the second guide tube, and the third guide tube allows the distal ends of the first guide tube, the second guide tube, and the third guide tube to press against the vessel wall”.
The term “to” on line 22 should be removed in order to be grammatically correct.
Appropriate correction is required.
Claim 46 is objected to because of the following informalities:
The phrase “the curve of the first guide tube, the second guide tube, and the third guide tube” on lines 9-10 lacks proper antecedent basis since this is the first time that such a “curve” is being introduced in the claim. Additionally, this language is grammatically incorrect because it sets forth that a single “curve” belongs to all three guide tubes. It is suggested to amend lines 9-11 to recite “wherein [[the]] a curve of each of the first guide tube, the second guide tube, and the third guide tube allows the distal ends of the first guide tube, the second guide tube, and the third guide tube to press against the vessel wall and begin to flex backwards”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 40 and 43 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Edwards (US Pat 5,588,960).
Re claim 40, Edwards discloses an ablation system 20 (Fig 1,2; it is noted that all references cited below refer to Fig 2 unless otherwise mentioned) comprising: a catheter body 22 having a central axis (extending horizontally in Fig 2); three guide tubes 52,52,52 (Fig 1 shoes four guide tubes 52) each having a distal end (to the right in Fig 2), comprising a first guide tube 52, a second guide tube 52, and a third guide tube 52, the first guide tube, the second guide tube, and the third guide tube configured to curve toward a vessel wall (as seen in Fig 2) with the distal ends of the first guide tube, the second guide tube, and the third guide tube together having a fully open configuration with a fixed maximum diameter (correlating to when handle 91 is pushed to its distal-most position to the right in Fig 2), wherein the curve of the first guide tube, the second guide tube, and the third guide tube allow the distal ends of the first guide tube, the second guide tube, and the third guide tube to press against the vessel wall when at the fixed maximum diameter (because guide tubes 52 press against the vessel wall as they penetrate it, Col 6, Lines 31-34); and three injectors 41,41,41 (Fig 1 shoes four injectors 41),e ach having a distal end (to the right in Fig 2) comprising a first injector 41, a second injector 41, and a third injector 41, wherein the first injector, the second injector, and the third injector are located coaxially inside of the first guide tube, the second guide tube, and the third guide tube, respectively, the three injectors having a pre-deployment configuration wherein the distal end of the first injector is parked just proximal to the distal end of the first guide tube (it is noted that, although the drawings do not show how far back from the distal-most end of the guide tubes that the injectors lie when in the pre-deployment configuration, (1) the specification does disclose that the injectors lie within the guide tubes in the pre-deployment configuration (Col 6, Lines 41-44) and (2) the disclosure does not define how far back from the distal-most end that the “distal end” can extend; that is, the term “end” is not limited to a specific distance – rather, the “distal end” as claimed can be the distal half of the guide tube; because the distal ends of the injectors are parked within the guide tubes in the pre-deployment configuration, they are parked “just proximal” to the distal ends of the guide tubes since the distal ends can extend proximally any distance from the distal-most end of the guide tubes to the halfway point of the guide tubes), wherein the distal end of the second injector is parked just proximal to the distal end of the second guide tube (see explanation above), wherein the distal end of the third injector is parked just proximal to the distal end of the third guide tube (see explanation above), wherein the first injector, the second injector, and the third injector are configured to advance relative to the first guide tube, the second guide tube, and the third guide tube, respectively, to penetrate tissue while the distal ends of the first guide tube, the second guide tube and the third guide tube to press against the vessel wall at the fixed maximum diameter (Col 6, Lines 50-55), wherein the distal ends of the first injector, the second injector, and the third injector are configured to together have a fixed penetration diameter (correlating to when handle 72 is pushed to its distal-most position to the right in Fig 2) greater than the fixed maximum diameter of the guide tubes through which the injectors advance (due to the arrangement of the handles seen in Fig 2, when handles 72 are pushed to their distal-most position to the right, the distal-most end of the needles (which define the fixed penetration diameter) will be further radially outward than the distal-most end of the guide tubes (which define the fixed maximum diameter)).
Re claim 43, Edwards discloses that the first injector, the second injector, and the third injector are between 25 gauge and 35 gauge (Col 3, Lines 25-26 disclose that the outer diameter of the injectors can be 0.3 mm which is between 25 gauge (0.5 mm) and 35 gauge (0.21 mm)).
Claims 40 and 44 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Blewett et al. (US Pat 6,106,521).
Re claim 40, Blewett discloses an ablation system (as seen in Fig 1,2,15,16; it is noted that all reference characters cited below refer to Fig 1,2,15,16 unless otherwise cited) comprising: a catheter body 24 having a central axis (extending horizontally in Fig 15 and out of the page in Fig 14); three guide tubes 36a (Col 7, Lines 43-44, “three or more delivery tubes”), each having a distal end (inherent, pointed downward in Fig 14), comprising a first guide tube 36a, a second guide tube 36a, and a third guide tube (not shown but disclosed in Col 7, Lines 43-44, “three or more delivery tubes”), the first guide tube, the second guide tube and the third guide tube configured to curve toward a vessel wall (as seen in Fig 16), wherein the distal ends of the first guide tube, the second guide tube, and the third guide tube together having a fully open configuration (Col 4, Lines 44-51) with a fixed maximum diameter (the “fixed maximum diameter” is the diameter achieved when the actuator 28 is moved to its maximum position, all the way to the left in Fig 5; Col 5, Lines 13-31), wherein the curve of the first guide tube, the second guide tube, and the third guide tube allow the distal ends of the first guide tube, the second guide tube, and the third guide tube to press against the vessel wall when at the fixed maximum diameter (although Blewett does not explicitly state that the guide tubes contact the vessel wall, the claim is not a method claim and, therefore, the guide tubes only have to be structurally capable of pressing against a vessel wall; since the system could be used in a vessel having an internal circumference equal to that of the distance the tubes 36 extend in Fig 14 (which is “slightly […] beyond the outer circumference of the apparatus 20”, Col 6, Lines 63-65)); three injectors 38a (Col 5, Lines 43-44, “three or more […] electrodes”), each having a distal end (pointed in Fig 16) comprising a first injector 38a, a second injector 38a, and a third injector (not shown but disclosed in Col 5, Lines 43-44, “three or more […] electrodes”), the first injector, the second injector and the third injector are located coaxially inside of the first guide tube, the second guide tube and the third guide tube, respectively, the three injectors having a pre-deployment configuration wherein the distal end of the first injector is parked just proximal to the distal end of the first guide tube (it is noted that, although the drawings do not show how far back from the distal-most end of the guide tubes that the injectors lie when in the pre-deployment configuration, (1) the specification does disclose that the injectors lie within the guide tubes in the pre-deployment configuration (Col 5, Lines 39-42) and (2) the disclosure does not define how far back from the distal-most end that the “distal end” can extend; that is, the term “end” is not limited to a specific distance – rather, the “distal end” as claimed can be the distal half of the guide tube; because the distal ends of the injectors are parked within the guide tubes in the pre-deployment configuration, they are parked “just proximal” to the distal ends of the guide tubes since the distal ends can extend proximally any distance from the distal-most end of the guide tubes to the halfway point of the guide tubes), wherein the distal end of the second injector is parked just proximal to the distal end of the second guide tube (see the explanation above), wherein the distal end of the third injector is parked just proximal to the distal end of the third guide tube (see the explanation above), wherein the first injector, the second injector, and the third injector are configured to advance relative to the first guide tube, the second guide tube, and the third guide tube, respectively, to penetrate tissue while the distal ends of the first guide tube, the second guide tube, and the third guide tube press against the vessel wall at the fixed maximum diameter (Col 5, Lines 39-42), wherein the distal ends of the first injector, the second injector, and the third injector are configured to together have a fixed penetration diameter greater than the fixed maximum diameter of the guide tubes through which the injectors advance (the “fixed penetration diameter” is the diameter achieved when the actuator 30 is moved to its maximum position, all the way to the left in Fig 5; Col 5, Lines 33-47; Fig 16 shows this to be greater than the fixed maximum diameter).
Re claim 44, Blewett discloses that the first guide tube, the second guide tube and the third guide tube are configured to press against, but not penetrate, a vessel wall at the fixed maximum diameter (Col 6, Lines 63-66).
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 negated by the manner in which the invention was made.
Claims 31, 33, 37, 38, 46 and 49-52 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Morris et al. (PG PUB 2006/0224118) in view of Makower et al. (PG PUB 2008/0051756).
Re claim 31, Morris discloses an ablation system 110 (Fig 8,9; it is noted that all reference characters cited below refer to Fig 8,9 unless otherwise cited) comprising: a catheter body 112 having a central axis (extending through the center of lumen 130); a first guide tube 120, a second guide tube 122, and a third guide tube 124, wherein the first guide tube assumes a first pre-set curve when extending outward from the catheter body (Para 47, “pre-formed curve”), wherein the second guide tube assumes a second pre-set curve when extending outward from the catheter body (Para 47, “pre-formed curve’), wherein the third guide tube assumes a third pre-set curve when extending outward from the catheter body (Para 47, “pre-formed curve”), each guide tube comprising a proximal end (unseen, to the right in Fig 9) and a distal end (pointed, seen to the left in Fig 9), wherein the distal ends of the first guide tube, the second guide tube, and the third guide tube are evenly spaced around a first circumference (seen in Fig 8, they are spaced evenly around the circumference of inner member 114) and together have a fixed maximum diameter in a fully open configuration (inherent as there is only a maximum distance that the guide tubes can be inserted).
Morris does not explicitly disclose that the embodiment of Fig 8,9 includes first, second and third injectors, each within a respective one of the first, second and third guide tubes.
The embodiment of Fig 7 teaches first and second guide tubes 80,84 (Fig 7) that assume a curve when extending outward from a catheter body 76 (Fig 7) (as seen in Fig 7), are spaced around a first circumference (as seen in Fig 7) and have a fixed maximum diameter in a fully open configuration (inherent as there is only a maximum distance that the guide tubes can be inserted) like the first, second and third guide tubes of the embodiment of Fig 8,9. Additionally, Morris teaches that the first and second guide tubes have first and second injectors 100,102 (Fig 7) located coaxially therein, respectively, wherein each injectors is shaped parallel to the curve of its respective guide tube to enhance coaxial movement of the injector within its guide tube (as seen in Fig 7; it is noted that the claim does not require the injectors to have a “pre- set curve’ like the guide tubes, but rather only requires that the injectors be parallel to the shape of the guide tube at some point in time), wherein the injectors are configured to advance relative to their respective guide tubes to penetrate tissue (Para 44, “deliver fluid into tissue located remotely from needle tips 82 and 86”), each injector comprising a proximal end (unseen, to the top in Fig 7) and a distal end (pointed, seen pointing downward in Fig 7), wherein the distal ends of the injectors are spaced around a second circumference (as seen in Fig 7) and together have a fixed penetration diameter greater than the fixed maximum diameter (inherent as there is only a maximum distance that the injectors can be inserted). Morris discloses that the addition of injectors within the guide tubes allows for medical fluid to be delivered into tissue located remotely from the tips of the guide tubes (Para 44). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the embodiment of Fig 8,9 to include an injector in each of the three guide tubes, as taught by the embodiment of Fig 7, for the purpose of allowing for medical fluid to be delivered into tissue located remotely from the tips of the guide tubes (Para 44).
Morris does not explicitly disclose int eh embodiment of Fig 7 that each of the injectors comprises its own pre-set curve.
Makower, however, teaches a system (Fig 2C) comprising a catheter body 10 (Fig 2C), a guide tube 85 (Fig 2C) that assumes a pre-set curve when extended outward from the catheter body (Para 53) and an injector 12 (Fig 2C) located coaxially inside the guide tube (as seen in Fig 2C), configured to advance relative to the guide tube (as seen in Fig 2B,2C), and comprising an injector pre-set curve which is shaped parallel to the pre-set curve of the guide tube to enhance coaxial movement of the injector within the guide tube (Para 65). Makower teaches that providing an injector with a pre-set curve allows the injector to follow a path of advancement which allows the injector to be advanced out of the guide tube to or away from specific zones that the operator wishes to reach or avoid (Para 53). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Morris to include the injectors with pre-set curves, as taught by Makower, for the purpose of allowing the injectors to follow paths of advancement which allow them to be advanced out of their guide tubes to or away from specific zones that are operator wishes to reach or avoid (Para 53).
Re claim 33, Morris discloses that the first guide tube, the second guide tube, and the third guide tube are configured for simultaneous movement (Para 44, “simultaneously’).
Re claim 37, Morris discloses that the first guide tube is configured to navigate a nearly right angle bend (Para 47, “along a pathway that becomes substantially co-planar with the targeted tissue’).
Re claim 38, Morris discloses that the first guide tube is configured to extend outward without inflation of a balloon (Para 38).
Re claim 46, Morris discloses an ablation system 110 (Fig 8,9; it is noted that all reference characters cited below refer to Fig 8,9 unless otherwise cited) comprising: a catheter body 112 having a central axis (extending through the center of lumen 130); a first guide tube 120, a second guide tube 122, and a third guide tube 124, wherein the first guide tube , the second guide tube and the third guide tube flare outward from the central axis (as seen in Fig 9) with distal ends of the first guide tube, the second guide tube, and the third guide tube together having a fixed maximum diameter (inherent as there is only a maximum distance that the guide tubes can be inserted), wherein a curve (Para 47, “pre-formed curve”) of each of the first guide tube, the second guide tube, and the third guide tube allow the distal ends of the first guide tube, the second guide tube, and the third guide tube to press against the vessel wall (since the guide tubes pierce the wall (as seen in Fig 10), they “press against” the wall as they move therethrough).
Morris does not explicitly disclose that the embodiment of Fig 8,9 includes first, second and third injectors, each within a respective one of the first, second and third guide tubes.
The embodiment of Fig 7 teaches first and second guide tubes 80,84 (Fig 7) that assume a curve when extending outward from a catheter body 76 (Fig 7) (as seen in Fig 7), are spaced around a first circumference (as seen in Fig 7) and have a fixed maximum diameter in a fully open configuration (inherent as there is only a maximum distance that the guide tubes can be inserted) like the first, second and third guide tubes of the embodiment of Fig 8,9. Additionally, Morris teaches that the first and second guide tubes have first and second injectors 100,102 (Fig 7) located coaxially therein, respectively, wherein the injectors are configured to advance relative to their respective guide tubes to penetrate tissue (Para 44, “deliver fluid into tissue located remotely from needle tips 82 and 86”), wherein the distal ends of the injectors are configured to together have a fixed penetration diameter greater than the fixed maximum diameter of the guide tubes through which the injectors advance (inherent as there is only a maximum distance that the injectors can be inserted). Morris discloses that the addition of injectors within the guide tubes allows for medical fluid to be delivered into tissue located remotely from the tips of the guide tubes (Para 44). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the embodiment of Fig 8,9 to include an injector in each of the three guide tubes, as taught by the embodiment of Fig 7, for the purpose of allowing for medical fluid to be delivered into tissue located remotely from the tips of the guide tubes (Para 44).
Morris does not explicitly disclose in either the embodiment of Figs 8,9 or the embodiment of Fig 7 that the distal ends of the guide tubes are tapered to provide a surface configured to be approximately parallel to a vessel wall when the guide tubes press against the vessel wall or that a curve of each of the guide tubes allows the distal ends of the guide tubes to press against the wall and begin to flex backwards.
Makower, however, teaches a system (Fig 2C) comprising a catheter body 10 (Fig 2C), a guide tube 85 (Fig 2C) having a curve when extended outward from the catheter body (Para 53) and an injector 12 (Fig 2C) located coaxially inside the guide tube (as seen in Fig 2C) and configured to advance relative to the guide tube (as seen in Fig 2B,2C), wherein the guide tube has a distal end (pointed in Fig 13) that is tapered to provide a surface configured to be approximately parallel to a vessel wall when the guide tube presses against the vessel wall (when in position PD of Fig 13) and that a curve of the guide tube allows the distal end of the guide tube to press against the wall and begin to flex backwards (seen when moving from initial position PA to position PD in Fig 13). Makower teaches that providing a guide tube with a tapered distal end and providing the guide tube with a curve such that it presses against a vessel wall and begins to flex backwards allows the guide tube to provide a pathway for the injector that allows the injector to deliver substance relatively uniformly over a generally wedge shaped region of tissue with only one penetration through the wall (Para 83). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Morris to include the guide tubes with tapered distal ends and to configure them to press against a vessel wall and begin to flex backwards, as taught by Makower, for the purpose of allowing the guide tube to provide a pathway for the injector that allows the injector to deliver substance relatively uniformly over a generally wedge shaped region of tissue with only one penetration through the wall (Para 83).
Re claim 49, Morris as modified by Makower in the rejection of claim 46 above disclose all the claimed features with Makower teaching that the first injector 12 comprises a radiopaque material (Para 62) for the purpose of permitting imaging of the injector to determine the position of the injector (Para 62). Therefore, it would have been obvious to one of ordinary skill in the art to modify the first injector to include a radiopaque material, as taught by Makower, for the purpose of permitting imaging of the first injector to determine the position of the first injector (Para 62).
Re claim 50, Morris discloses that the first guide tube comprises a radiopaque material (stainless steel, as disclosed in Para 32, is known to be radiopaque).
Re claim 51, Morris as modified by Makower in the rejection of claim 46 above disclose all the claimed features with Makower teaching that the first guide tube, the second guide tube, and the third guide tube are configured to flex backwards into engagement with the vessel wall (as seen in Fig 13, Para 83). The motivation cited in the rejection of claim 46 above also applied to claim 51.
Re claim 52, Morris discloses that the first guide tube, the second guide tube and the third guide tube are evenly spaced (as seen in Fig 8).
Claims 32, 47 and 48 is rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Morris et al. (PG PUB 2006/0224118)/Makower et al. (PG PUB 2008/0051756) in view of Edwards et al. (US Pat 5,588,960).
Re claim 32, Morris/Makower discloses all the claimed features but Morris is silent as to whether or not all three injectors are configured for simultaneous movement. Edwards, however, teaches an ablation system 20 (Fig 1,2; it is noted that all reference characters cited below refer to Fig 1,2 unless otherwise cited) comprising a catheter body 22, three guide tubes 52,52,52 (Fig 1 shows four guide tubes 52), and three injectors 41,41,41 (Fig 1 shows four injectors 41), wherein the three injectors are configured for simultaneous movement (via handle 72; Col 4, Lines 22-25 and Col 6, Lines 5-8,26-34) for the purpose of providing injection in the same plane (Col 3, Lines 14-18). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Morris to include the injectors so that they are configured for simultaneous movement, as taught by Edwards, for the purpose of providing injection from all of the injectors in the same plane (Col 3, Lines 14-18).
Re claim 47, Morris/Makower disclose all the claimed features except that the advancement of the three injectors are controlled by a single injector handle. Edwards, however, teaches an ablation system 20 (Fig 1,2; it is noted that all reference characters cited below refer to Fig 1,2 unless otherwise cited) comprising a catheter body 22, three guide tubes 52,52,52 (Fig 1 shows four guide tubes 52), and three injectors 41,41,41 (Fig 1 shows four injectors 41), wherein advancement of the three injectors are controlled by a single injector handle 72 (Fig 1,2; Col 4, Lines 22-25 and Col 6, Lines 5-8,26-34) for the purpose of providing injection in the same plane (Col 3, Lines 14-18). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Morris to include the injectors so that they are controlled by a single handle, as taught by Edwards, for the purpose of providing injection from all of the injectors in the same plane (Col 3, Lines 14-18).
Re claim 48, Morris/Makower disclose all the claimed features except that the advancement of the three guide tubes are controlled by a single guide tube handle. Edwards, however, teaches an ablation system 20 (Fig 1,2; it is noted that all reference characters cited below refer to Fig 1,2 unless otherwise cited) comprising a catheter body 22, three guide tubes 52,52,52 (Fig 1 shows four guide tubes 52), and three injectors 41,41,41 (Fig 1 shows four injectors 41), wherein advancement of the three guide tubes are controlled by a single guide tube handle 91 (Fig 1,2; Col 4, Lines 38-43 and Col 6, Lines 5-8, 26-40) for the purpose of ensuring that penetration depth of the guide tubes – which dictates delivery depth through the injectors – is uniform (Col 6, Lines 26-40). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Morris to include the guide tubes so that they are controlled by a single handle, as taught by Edwards, for the purpose of ensuring that penetration depth of the guide tubes – which dictates delivery depth through the injectors – is uniform (Col 6, Lines 26-40).
Claims 34 and 35 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Morris et al. (PG PUB 2006/0224118)/Makower et al. (PG PUB 2008/0051756) in view of Edwards et al. (PG PUB 2010/0114087)
Re claim 34, Morris/Makower discloses all the claimed features except that the first guide tube comprises a two layer tube. Edwards, however, teaches a substantially similar ablation system (Fig 15) comprising a catheter body 21 (Fig 2; Para 80), guide tubes 44 (Fig 15) that extend outward therefrom, and injectors 90 (Fig 15) that extend from the guide tubes, wherein the guide tubes, like Morris, are formed with a pre-set curve (Para 82), wherein the material used is a two layer tube formed of wire reinforced plastic tubing (Para 82). Since Edwards teaches that a two layer tube formed of wire reinforced plastic tubing can achieve the same result as the material used in Morris’s guide tubes, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Morris to include the first guide tube such that it is formed of a two layer tube formed of wire reinforced plastic tubing, as taught by Edwards, since it has been held that the substitution of one material for an equivalent material involves only routine skill in the art.
Re claim 35, Morris/Makower discloses all the claimed features except that the first guide tube comprises a plastic material. Edwards, however, teaches a substantially similar ablation system (Fig 15) comprising a catheter body 21 (Fig 2; Para 80), guides tube 44 (Fig 15) that extend outward therefrom, and injectors 90 (Fig 15) that extend from the guide tubes, wherein the guide tubes, like Morris, are formed with a pre-set curve (Para 82), wherein the material used is wire reinforced plastic tubing (Para 82). Since Edwards teaches that tube formed of wire reinforced plastic tubing can achieve the same result as the material used in Morris’s guide tubes, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Morris to include the first guide tube such that it is formed of wire reinforced plastic tubing, as taught by Edwards, since it has been held that the substitution of one material for an equivalent material involves only routine skill in the art.
Claims 41, 42 and 45 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Edwards (US Pat 5,588,960).
Re claim 41, Edwards discloses all the claimed features except that the fixed maximum diameter of the guide tubes is between 3 mm and 10 mm. However, it would have been an obvious matter of design choice to provide the guide tubes with a fixed maximum diameter between 3 mm and 10 mm since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. This claim has additionally been rejected with art below.
Re claim 42, Edwards discloses all the claimed features except that the catheter body has a diameter that is less than 2 mm. However, it would have been an obvious matter of design choice to provide the catheter body with a diameter less than 2 mm since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Re claim 45, Edwards discloses all the claimed features except that the fixed penetration diameter of the injectors extends between 0.5 mm and 3 mm beyond the fixed maximum diameter. However, it would have been an obvious matter of design choice to provide the injectors with a length so that they extend between 0.5 mm and 3 mm beyond the guide tubes since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Alternatively, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the injectors with a length so that they extend between 0.5 mm and 3 mm beyond the guide tubes since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Claims 41 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards (UG Pat 5,588,960) in view of Lundquist et al. (US Pat 5,549,644).
Re claim 41, Edwards discloses all the claimed features except that the fixed maximum diameter of the guide tubes is between 3 mm and 10 mm. Lundquist, however, teaches a substantially similar ablation system (seen in Fig 29,31) comprising guide tubes 52 (Fig 31) that extend outward from a longitudinal axis (as seen in Fig 31) and injectors 116 (Fig 31) that extend outwardly therefrom to pierce tissue (as seen in Fig 31), wherein the guide tubes have a fixed maximum diameter between 5 and 10 mm (Col 16, Lines 29-34); Lundquist teaches that providing guide tubes with such a fixed maximum diameter is appropriately sized for use in the urethra (Col 16, Lines 14-24). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Edwards to include the guide tubes with a fixed maximum diameter between 3 and 10 mm, as taught by Lundquist, for the purpose of ensuring proper sizing for use in the urethra (Col 16, Lines 14-24).
Claims 41-43 and 45 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Blewett et al. (US Pat 6,106,521).
Re claim 41, Blewett discloses all the claimed features except that the fixed maximum diameter of the guide tubes is between 3 mm and 10 mm. However, it would have been an obvious matter of design choice to provide the guide tubes with a fixed maximum diameter between 3 mm and 10 mm since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. This claim has additionally been rejected with art below.
Re claim 42, Blewett discloses all the claimed features except that the catheter body has a diameter that is less than 2 mm. However, it would have been an obvious matter of design choice to provide the catheter body with a diameter less than 2 mm since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Re claim 43, Blewett discloses all the claimed features except that the first, second and third injectors are between 25 gauge and 35 gauge. However, it would have been an obvious matter of design choice to provide the injectors such that they are between 25 gauge and 35 gauge since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. This claim has additionally been rejected with art below.
Re claim 45, Blewett discloses all the claimed features except that the fixed penetration diameter of the injectors extends between 0.5 mm and 3 mm beyond the fixed maximum diameter. However, it would have been an obvious matter of design choice to provide the injectors with a length so that they extend between 0.5 mm and 3 mm beyond the guide tubes since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Alternatively, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the injectors with a length so that they extend between 0.5 mm and 3 mm beyond the guide tubes since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Claims 41 and 43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Blewett et al. (US Pat 6,106,521) in view of Lundquist et al. (US Pat 5,549,644).
Re claim 41, Blewett discloses all the claimed features except that the fixed maximum diameter of the guide tubes is between 3 mm and 10 mm. Lundquist, however, teaches a substantially similar ablation system (seen in Fig 29,31) comprising guide tubes 52 (Fig 31) that extend outward from a longitudinal axis (as seen in Fig 31) and injectors 116 (Fig 31) that extend outwardly therefrom to pierce tissue (as seen in Fig 31), wherein the guide tubes have a fixed maximum diameter between 5 and 10 mm (Col 16, Lines 29-34); Lundquist teaches that providing guide tubes with such a fixed maximum diameter is appropriately sized for use in the urethra (Col 16, Lines 14-24). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Blewett to include the guide tubes with a fixed maximum diameter between 3 and 10 mm, as taught by Lundquist, for the purpose of ensuring proper sizing for use in the urethra (Col 16, Lines 14-24).
Re claim 43, Blewett discloses all the claimed features except that the injectors are between 25 gauge and 35 gauge. Lundquist, however, teaches a substantially similar ablation system (seen in Fig 29,31) comprising guide tubes 52 (Fig 31) that extend outward from a longitudinal axis (as seen in Fig 31) and injectors 116 (Fig 31) that extend outwardly therefrom to pierce tissue (as seen in Fig 31), wherein the injectors are between 25 gauge and 35 gauge (“a diameter of 0.017 inches”, Col 7, Lines 22-24; a diameter of 0.017 inches is between 26 and 27 gauge); Lundquist teaches that injectors of such a size leave only small holes in the urethral wall that can rapidly heal (Col 21, Lines 50-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Blewett to include the injectors such that they are between 25 gauge and 35 gauge, as taught by Lundquist, for the purpose of ensuring that the holes left behind by the injectors are able to rapidly heal (Col 22, Lines 49-51).
Response to Arguments
Applicant's arguments filed 7/21/2025 have been fully considered. They amount to a general allegation that the claims overcome the previously-cited prior art without explicitly showing how they overcome the cited art. The argument directed to claim 31 is moot in view of the above rejections that modify Morris with Makower to teach the amended features. The arguments directed to claim 40 are not persuasive since, as set forth above, Edwards and Blewett each still read upon the amended features. The argument directed to claim 46 is moot in view of the above rejections that no longer utilize the previously-cited Chan reference and, instead, now utilize Morris in combination with Makower to teach the subject matter of the claim.
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.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783