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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/05/2026 has been entered.
Response to Amendment
The Amendments filed July 15, 2026 have been entered. Applicant’s amendments have overcome the Specification objection filed on the Final Office Action mailed on 05/20/2026. Currently, claims 1, 12, and 20 have been amended, and claims 1-20 are pending in the application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu (U.S. Patent No. 7871395 B2).
Regarding independent claim 1, Hu discloses a catheter system for treating a treatment site (vasculature) within or adjacent to a vessel wall or a heart valve within a body of a patient (Col. 2, lines 25-39 & Fig. 1), the catheter system including a first energy guide (36) and a second energy guide (40) (Col. 3, lines 62-66 & Fig. 4), the catheter system comprising:
a routing assembly (combination of housing 32 and separation element 44) (Col. 4, lines 9-17) that defines a routing space (i.e., a cavity or interior space seen inside the housing 32) that retains a routing length of each of the energy guides (Col. 3, lines 60-67 – Col. 4, lines 1-5), the routing assembly including an inner routing guide (path 46) extending across the routing space (Col. 4, lines 25-28) and comprising a guide retainer (external annular surface of separation element 44; Col. 4, lines 9-20) attached to and extending radially outward from an outer surface of the inner routing guide (see Fig. 4), the routing length of each of the energy guides being at least partially disposed about the inner routing guide (the first energy guide is wrapped around the separation element, while the second energy is disposed on the path, Col. 4, lines 25-34), the routing space being configured so that the routing length of at least one of the energy guides is adjustable (Col. 4, lines 40-52 & Fig. 5).
Regarding claims 2 and 14, Hu discloses wherein each of the energy guides includes an optical fiber (Col. 2, lines 58-63).
Regarding claims 3 and 15, Hu discloses wherein each of the energy guides includes a guide distal end (located on housing 32 as seen in Fig. 3, Col. 3, lines 42-52) and a guide proximal end (located on a second connector 24, as seen in Fig. 1, that is matable with an electrical umbilical (not shown) that can further include an accessory box (not shown), Col. 3, lines 1-5).
Regarding claims 4 and 16, Hu discloses wherein the guide proximal end is fixed relative to the routing assembly (see Fig. 1).
Regarding claims 5 and 17, Hu discloses wherein the guide distal end is movable relative to the routing assembly (Col. 3, lines 47-59).
Regarding claims 6 and 18, Hu discloses wherein each energy guide is positioned at least approximately 90 degrees about the inner routing guide (see Fig. 4).
Since the first energy guide is spirally wound about the inner routing guide, at least a portion of the first energy guide is positioned at least 90 degrees about the inner routing guide. Moreover, the second energy guide is positioned perpendicularly relative to a vertical axis of the inner routing guide.
Regarding claims 7 and 19, Hu discloses comprising an adapter assembly (see annotated Fig. 1 below) that houses the inner routing guide.
The adapter assembly includes components such as a proximal portion of the handle’s outer shell/casing (as seen by the dotted line below), a first connector 22, a second connector 24, an intermediate portion and a proximal end of each of the energy guides, a pressure sensor 34′, and the routing assembly comprising the inner routing guide.
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Regarding claim 8, Hu discloses comprising an electrical cable (i.e., the energy guides are not limited to a single element/structure, and may include wiring, cables, and/or fiber optic elements, Col. 2, lines 58-63) that is positioned about the inner routing guide. Furthermore, the inner routing guide may include multiple paths for additional cables coupled to the medical device to aid in reducing the likelihood of tangling, kinking, or the like (Col. 4, lines 34-39).
Regarding claim 9, Hu discloses wherein each energy guide includes an optical guide (12) that protects each energy guide (Col. 2, lines 55-58).
Regarding claim 10, Hu discloses further comprising a handle assembly (see annotated Fig. 1 above on page 4; the handle assembly includes components such as a distal portion of the handle’s outer shell/casing (as seen by the dotted line above), a cam 20 in communication with and responsive to a lever 18 in order to control pull wires, and a pressure sensor 34) that is usable by a user to selectively position the energy guides near the treatment site (Col. 2, lines 49-51), the routing assembly being positioned outside of the handle assembly (see annotated Fig. 1 above on page 4).
Examiner is using Applicant’s definition of the phrase “outside of”, as described in page 23, third paragraph of the filed Specification, as also meaning spaced apart from. Therefore, as seen in figure 1 of the Hu reference, the routing assembly is positioned outside of/spaced apart from the handle assembly.
Regarding claims 11 and 13, Hu discloses further comprising a connector assembly (see annotated Fig. 1 below) that more closely positions the energy guides together (towards a second connector 24; Col. 3, lines 1-5), the routing assembly being positioned within the connector assembly.
The connector assembly includes components such as a proximal portion of the handle’s outer shell/casing (as seen by the dotted line below), a first connector 22, the second connector 24, an intermediate portion and a proximal end of each of the energy guides (Col. 3, lines 1-5), a pressure sensor 34′, and the routing assembly comprising the inner routing guide.
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Regarding independent claim 12, Hu discloses a catheter system for treating a treatment site (vasculature) within or adjacent to a vessel wall or a heart valve within a body of a patient (Col. 2, lines 25-39 & Fig. 1), the catheter system including a first energy guide (36) and a second energy guide (40) (Col. 3, lines 62-66 & Fig. 4), the catheter system comprising:
a handle assembly (see annotated Fig. 1 below; the handle assembly includes components such as a distal portion of the handle’s outer shell/casing (as seen by the dotted line above), a cam 20 in communication with and responsive to a lever 18 in order to control pull wires, and a pressure sensor 34) that is usable by a user to selectively position the energy guides near the treatment site (Col. 2, lines 49-51); and
a routing assembly (combination of housing 32 and separation element 44) (Col. 4, lines 9-17) that defines a routing space (i.e., a cavity or interior space seen inside the housing 32) that retains a routing length of each of the energy guides (Col. 3, lines 60-67 – Col. 4, lines 1-5), the routing assembly being positioned outside of and proximal of the handle assembly (see annotated Fig. 1 below), the routing assembly including an inner routing guide (path 46) that is positioned within the routing space (Col. 4, lines 25-28) and comprising a guide retainer (external annular surface of separation element 44; Col. 4, lines 9-20) attached to and extending radially outward from an outer surface of the inner routing guide (see Fig. 4), the routing length of each of the energy guides being positioned at least partially about the inner routing guide (the first energy guide is wrapped around the separation element, while the second energy guide is disposed on the path; Col. 4, lines 25-34), the routing space being configured so that the routing length of at least one of the energy guides is adjustable (Col. 4, lines 40-52 & Fig. 5).
Examiner is using Applicant’s definition of the phrase “outside of”, as described in page 23, third paragraph of the filed Specification, as also meaning spaced apart from. Therefore, as seen in figure 1 of the Hu reference, the routing assembly is positioned outside of/spaced apart from the handle assembly.
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Regarding independent claim 20, Hu discloses a catheter system for treating a treatment site (vasculature) within or adjacent to a vessel wall or a heart valve within a body of a patient (Col. 2, lines 25-39 & Fig. 1), the catheter system including a first energy guide (36) and a second energy guide (40) (Col. 3, lines 62-66 & Fig. 4), the catheter system comprising:
a handle assembly (see annotated Fig. 1 below; the handle assembly includes components such as a distal portion of the handle’s outer shell/casing (as seen by the dotted line above) and a cam 20 in communication with and responsive to a lever 18 in order to control pull wires) that is usable by a user to selectively position the energy guides near the treatment site (Col. 2, lines 49-51);
a connector assembly (see annotated Fig. 1 below; the connector assembly includes components such as a proximal-most portion of the handle’s outer shell/casing (as seen by the dotted line below), a first connector 22, and a second connector 24; (Col. 3, lines 1-5)) proximal of the handle assembly that brings each of the energy guides closer together (towards the second connector) as the energy guides extends distally through the connector assembly so that the energy guides are in a more compact form (Col. 3, lines 1-5); and
a routing assembly (combination of an intermediate portion of the handle’s outer shell/casing (as seen by the dotted line below) an intermediate portion of each of the energy guides, and a pressure sensor 34′,) that defines a routing space (i.e., a cavity or interior space of the intermediate portion of the handle’s outer shell/casing) that retains a routing length of each of the energy guides (Col. 3, lines 60-67 – Col. 4, lines 1-5), the routing assembly being positioned outside of and proximal of the handle assembly (see annotated Fig. 1 below), the routing assembly including an inner routing guide (path 46; Col. 4, lines 25-28) and an outer routing guide (housing 32, including the external annular surfaces/diameters that protrude a proximal section of the housing and that make up a first opening 34 and a second opening 38; Col. 3, lines 60-67 – Col. 4, lines 1-8) that are positioned within the routing space (see annotated Fig. 1 below), wherein the inner routing guide comprises a first guide retainer (external annular surface of separation element 44; Col. 4, lines 9-20) attached to and extending radially outward from an outer surface of the inner routing guide (see Fig. 4), and wherein the outer routing guide comprises a second guide retainer (combination of internal annular surfaces/diameters that protrude the proximal section of the housing and that makes up the first opening 34 and the second opening 38) attached to and extending radially inward from an inner surface of the outer routing guide (see Fig. 4), and wherein the routing length of each of the energy guides being positioned at least partially about the inner routing guide (Col. 4, lines 9-20), the routing space being configured so that the routing length of at least one of the energy guides is adjustable (Col. 4, lines 40-52 & Fig. 5), each of the energy guides being positioned at least approximately 90 degrees about the inner routing guide (see Fig. 4). Since the first energy guide is spirally wound about the separation element, at least a portion of the first energy guide is positioned at least 90 degrees about the inner routing guide. Moreover, the second energy guide is positioned perpendicularly relative to a vertical axis of the inner routing guide.
Examiner is using Applicant’s definition of the phrase “outside of”, as described in page 23, third paragraph of the filed Specification, as also meaning spaced apart from. Therefore, as seen in the annotated figure 1 of the Hu reference below, the routing assembly is positioned outside of/spaced apart from the handle assembly.
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Response to Arguments
Applicant's arguments filed 07/15/2026 have been fully considered but they are not persuasive.
With regards to newly amended independent claims 1 and 12, Applicant argues that the Hu reference does not disclose the claim limitation of “the routing assembly including an inner routing guide extending across the routing space and comprising a guide retainer attached to and extending radially outward from an outer surface of the inner routing guide, the routing length of each of the energy guides being at least partially disposed about the inner routing guide”. However, Examiner, respectfully, disagrees.
In a new interpretation of the prior art, the Hu reference now discloses a routing assembly (combination of housing 32 and separation element 44) (Col. 4, lines 9-17) that defines a routing space (i.e., a cavity or interior space seen inside the housing 32), the routing assembly including an inner routing guide (path 46) extending across the routing space (Col. 4, lines 25-28) and comprising a guide retainer (external annular surface of separation element 44; Col. 4, lines 9-20) attached to and extending radially outward from an outer surface of the inner routing guide (see Fig. 4), the routing length of each of the energy guides being at least partially disposed about the inner routing guide (the first energy guide is wrapped around the separation element, while the second energy is disposed on the path, Col. 4, lines 25-34). Therefore, for the reasoning set-forth above, the rejection using the Hu reference is maintained.
With regards to newly amended independent claim 20, Applicant argues that the Hu reference does not disclose the claim limitation of “the routing assembly including an inner routing guide and an outer routing guide that are positioned within the routing space, wherein the inner routing guide comprises a first guide retainer attached to and extending radially outward from an outer surface of the inner routing guide, and wherein the outer routing guide comprises a second guide retainer attached to and extending radially inward from an inner surface of the outer routing guide”. However, Examiner, respectfully, disagrees.
In a new interpretation of the prior art, the Hu reference now discloses a routing assembly (combination of an intermediate portion of the handle’s outer shell/casing (as seen by the dotted line of annotated Fig. 1 below the rejection of claim 20 above) an intermediate portion of each of the energy guides, and a pressure sensor 34′,) that defines a routing space (i.e., a cavity or interior space of the intermediate portion of the handle’s outer shell/casing) that retains a routing length of each of the energy guides (Col. 3, lines 60-67 – Col. 4, lines 1-5), the routing assembly including an inner routing guide (path 46; Col. 4, lines 25-28) and an outer routing guide (housing 32, including the external annular surfaces/diameters that protrude a proximal section of the housing and that make up a first opening 34 and a second opening 38; Col. 3, lines 60-67 – Col. 4, lines 1-8) that are positioned within the routing space (see annotated Fig. 1 below), wherein the inner routing guide comprises a first guide retainer (external annular surface of separation element 44; Col. 4, lines 9-20) attached to and extending radially outward from an outer surface of the inner routing guide (see Fig. 4), and wherein the outer routing guide comprises a second guide retainer (combination of internal annular surfaces/diameters that protrude the proximal section of the housing and that makes up the first opening 34 and the second opening 38) attached to and extending radially inward from an inner surface of the outer routing guide (see Fig. 4). Hence, due to the reasoning set-forth above, the rejection using the Hu reference is maintained.
Conclusion
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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