DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendments filed March 18, 2026 have been entered. Currently, claims 1, 12, and 20 have been amended, and claims 1-20 are pending in the application.
Specification
The disclosure is objected to because of the following informalities: the “electrical cable 280” as seen in the last line of page 21 is incorrectly labeled and should instead be electrical cable 281.
Appropriate correction is required.
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 (44) comprising a post extending across the routing space (Col. 4, lines 9-20), the routing length of each of the energy guides being at least partially disposed about the post (the first energy guide is wrapped around the post of the inner routing guide, while the second energy is disposed on path/channel 46 of the post of the inner routing guide, 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 energy guide is positioned at least 90 degrees about the inner routing guide. Moreover, the second energy 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 (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.
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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.
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 (44) that is positioned within the routing space (Col. 4, lines 9-20), 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 post of the inner routing guide, while the second energy is disposed on path/channel 46 of the post of the inner routing guide, 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).
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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 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), 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);
a connector assembly (see annotated Fig. 1 below; 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, a 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) proximal of the handle assembly that brings each of the energy guides closer together (towards a second connector 24) 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 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 Fig. 1 below), the routing assembly including an inner routing guide (44) that is positioned within the routing space (pa. 0084), 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 inner routing guide, at least a portion of the energy guide is positioned at least 90 degrees about the inner routing guide. Moreover, the second energy 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 figure 1 of the Hu reference, the routing assembly is positioned outside of/spaced apart from the handle assembly.
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Response to Arguments
Applicant’s arguments, see pages 6-7, filed 03/18/2026, with respect to the 102 rejection of claims 1-20 under the Hane reference has been fully considered and are persuasive. Specifically, Applicant’s amendments to claims 1, 12, and 20 to further require the catheter system to include the features of an inner routing guide comprising a post extending across the routing space, the routing assembly being positioned outside of and proximal of the handle assembly, and the connector assembly being proximal of the handle assembly are defined over Hane given that it does not contemplate these claimed structures. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hu (U.S. Patent No. 7871395 B2).
It is the Examiner’s position that the newly filed rejections based on the Hue reference is tenable for at least the reasoning set forth in the action above.
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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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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