DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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 .
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/20/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 10/20/2025.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Specification
The disclosure is objected to because of the following informalities: amend the first paragraph with updated patent information for the priority application.
Appropriate correction is required.
Claim Notes
The Examiner notes that there are inconsistencies throughout the claims when referring to “plurality of microelectrodes”, “microelectrodes”, “plurality of spines”, “each spine”, “one spine”, “adjacent spines”. Suggestions are made below in the claim objections and/or 35 USC 112(b)/second paragraph rejections, but it is suggested to amend the claims to clarify which microelectrodes and spines are being referred to throughout the claims by further defining the plurality of microelectrodes and spines (e.g., -each of the plurality of spines carrying at least two of the plurality of microelectrodes-).
Claim Objections
Claim 7 is objected to because of the following informalities: amend “adheres” to -is adhered to- in ll. 2. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “the stem” to -the proximal stem- in ll. 10. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “each spine cover” to -each of the plurality of nonconductive spine covers- in ll. 11. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “a respective spine” to -a respective spine of the plurality of spines- in ll. 11-12. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend "the microelectrodes" to -the plurality of microelectrodes- in ll. 13. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend "each microelectrode" to -each of the plurality of microelectrodes- in ll. 17. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “the spines” to -the plurality of spines- in ll. 13. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “a respective microelectrode” to -a respective microelectrode of the plurality of microelectrodes- in ll. 20. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “in defining” to -and defining- in ll. 27. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “the inner lumen” to -the inner lumen of the proximal stem- in ll. 27. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “the outer surface” to -the outer surface of the insert- in ll. 28. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “each spine cover” to -each of the plurality of nonconductive spine covers- in ll. 10. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “a respective spine” to -a respective spine of the plurality of spines- in ll. 10-11. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “the spines” to -the plurality of spines- in ll. 12. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend "the microelectrodes" to -the plurality of microelectrodes- in ll. 12, 16, 18, 19, 20. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “the spines” to -the plurality of spines- in ll. 13. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “a first spine” to -a first spine of the plurality of spines- in ll. 14. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “a second spine” to -a second spine of the plurality of spines- in ll. 17. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “each microelectrode” to -each microelectrode of the plurality of microelectrodes- in ll. 18-19. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “a respective microelectrode” to -a respective microelectrode of the plurality of microelectrodes- in ll. 22. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: amend “a second separation distance” to -a second separation distance from each other- in ll. 3. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “the microelectrodes” to -the plurality of microelectrodes- in ll. 1. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “the microelectrodes” to -the plurality of microelectrodes- in ll. 1. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: amend “The microelectrodes” to -the plurality of microelectrodes- in ll. 1-2. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: amend “the microelectrodes” to -the plurality of microelectrodes- in ll. 1-2. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: amend “adheres” to -is adhered to- in ll. 2. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: amend “microelectrodes” to -microelectrodes of the plurality of microelectrodes- in ll. 2. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “microelectrodes” to -microelectrodes of the plurality of microelectrodes- in ll. 2. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “microelectrodes” to -microelectrodes of the plurality of microelectrodes- n ll. 2. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: amend “The spines” to -the plurality of spines- in ll. 8. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: amend “the spines” to -the plurality of spines- in ll. 7. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: amend “the spines” to -the plurality of spines- in ll. 7. Appropriate correction is required.
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 2-3 & 5-22 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 9 recites “a plurality of microelectrodes carried on the spines, the microelectrodes arranged in a staggered configuration between the first spines and the second spines, wherein a most proximal microelectrode on each first spine is positioned at a greater distance from the proximal stem, and a most proximal electrode on each second spine is positioned at a lesser distance from the proximal stem, each microelectrode defining a concentricity, and the concentricities of the microelectrodes on one spine are different from the concentricities of microelectrodes on adjacent spines when the plurality of spines is in an expanded configuration”. The limitation recites only one electrode of the plurality of microelectrodes on each first spine and only one electrode of the plurality of microelectrodes on each second spine and does not recite more than one microelectrode on each first spine nor each second spine. Thus, it is unclear to what “microelectrodes on one spine” and “microelectrodes on adjacent spines” are being referred to in the limitation. Claim 3 also recites “the microelectrodes on the first spines” and “the microelectrodes on the second spines” and will need to be amended accordingly.
Claim 10 recites “a plurality of microelectrodes carried on the spines, the microelectrodes arranged in a staggered configuration between adjacent ones of the plurality of spines, wherein a most proximal microelectrode on a first spine is positioned at a greater distance from the proximal stem, a most proximal electrode on an adjacent second spine is positioned at a lesser distance from the proximal stem, the microelectrodes on the first spine have a first separation distance from each other, and the microelectrodes on the second spine have a second separation distance from each other, wherein the first and second separation distances are different, each microelectrode defining a concentricity, and the concentricities of the microelectrodes on one spine are different from the concentricities of microelectrodes on adjacent spines when the plurality of spines is in an expanded configuration”. The limitation recites only one electrode of the plurality of microelectrodes on each first spine and only one electrode of the plurality of microelectrodes on each second spine and does not recite more than one microelectrode on each first spine nor each second spine. Thus, it is unclear to what “microelectrodes on one spine” and “microelectrodes on adjacent spines” are being referred to in the limitation.
Claims 2-3, 5-8 & 11-22 depend from claims 9-10 and are thus also rejected.
Claim 2 recites “at least four spines and four second spines”. It is unclear if these are the same as or different from the “plurality of spines” recited in claim 9. For purposes of examination, they will be interpreted as being the same.
Claim 2 recites “six microelectrodes”. It is unclear if these are the same as or different from the “plurality of microelectrodes” recited in claim 9. For purposes of examination, they will be interpreted as being the same.
Claim 7 recites “a textured outer surface of the insert”; however, claim 9, upon which claim 7 depends, recites “the insert including an outer surface”. It is unclear if the “textured outer surface” of claim 7 is the same as or different from that of claim 9. For purposes of examination, they will be interpreted as being the same.
Claim 11 recites “at least eight spines”. It is unclear if these are the same as or different from the “plurality of spines” recited in claim 9. For purposes of examination, they will be interpreted as being the same.
Claim 14 recites “a textured outer surface of the insert”; however, claim 10, upon which claim 14 depends, recites “the insert including an outer surface”. It is unclear if the “textured outer surface” of claim 14 is the same as or different from that of claim 10. For purposes of examination, they will be interpreted as being the same.
Claim 20 recites the limitation “a crouched generally forward-facing concavity”. It is unclear what is meant by “generally forward-facing concavity”. The term “generally” in claim 20 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination, the claim will be examined as -a crouched forward-facing concavity-.
Claim 22 recites “the deformed configuration having a lower profile”. It is unclear what is meant by “lower”. There is no mention in the originally filed disclosure of a “lower profile” configuration and “lower” can be defined in various ways: “relatively low in position, rank, or order”, “situated or held to be situated beneath the earth’s surface” (www.m-w.com). For purposes of examination, the claim will be examined as -a profiled that is smaller in height-.
Claim Interpretation
Claims 7 & 14 recite the limitation “the adhesive adheres to a textured outer surface of the insert” which is regarded as a product-by-process limitation.
Claim 16 recites the limitation “unique staggered configuration”. The term “unique” can be defined as “being the only one” (www.m-w.com), and thus is not regarded as a relative term and indefinite and interpreted as each spine have a different staggered microelectrode configuration.
Claim 20 recites the limitation “crouched generally forward-facing concavity”. The term “crouched” can be defined as “to stand at a low height” (www.m-w.com), and thus is not regarded as a relative term and indefinite.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 9-13, 2-3 & 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mest (2005/0090728) in view of Just et al. (2013/0172715) and Diep et al. (2014/0194716).
Concerning claim 9, as illustrated in at least Figs. 1-9, Mest discloses an electrophysiology catheter (catheter 10 can be used for electrophysiology; [0022]) comprising:
an elongated body defining a longitudinal axis (elongated catheter body 12; [0022]);
a distal electrode assembly distal of the elongated body (mapping assembly 15 mounted at the distal end of body 12; [0022]) and comprising:
a unibody support member (support structure 120 is manufactured from a single tube and has a unitary structure; [0059-0060]) including a proximal stem with a first length along the longitudinal axis (base 122 has a first length; [0059]), an inner lumen (interior or base 122 has an inner lumen), and a plurality of spines emanating from a distal end of the proximal stem (plurality of support arms 124 extending from the base; [0059]), the proximal stem configured to define a circumference around the longitudinal axis (base 122 defines a circumference around the longitudinal axis), and proximal ends of the plurality of spines extending from the distal end of the proximal stem and emanating from the circumference defined by the proximal stem (plurality of support arms 124 extending from the base; [0059]), each of the plurality of spines terminating in a free distal end (tips 127; [0061]), and the plurality of spines alternating between first spines and second spines around the circumference of the stem (multiple spines around the circumference of base 122);
a plurality of nonconductive spine covers, each spine cover surrounding a respective spine (each spine 118 comprises a support arm 124 and a non-conductive covering 134 in surrounding relation to the support arm 124; [0054]);
a plurality of microelectrodes carried on the spines (ring electrodes 125 are mounted on the non-conductive covering 134 of each spine 118; [0055]);
a plurality of lead wires, each connected to a respective microelectrode (each ring electrode 125 is electrically connected to an electrode lead wire 129; [0056]);
an elongated irrigation tubing extending through the elongated body and the proximal stem, the irrigation tubing including a distal end coextensive with a distal end of the proximal stem (infusion lumen 30 connected to needle electrode assembly 46 having distal tube 35 is used to inject saline or other fluid and is extendable and retractable, and may be moved by manipulation of the needle control handle 17 such that the distal end is coextensive with the distal end of base 122; [0035]).
Mest fails to disclose the microelectrodes arranged in a staggered configuration between the first spines and the second spines, wherein a most proximal microelectrode on each first spine is positioned at a greater distance from the proximal stem, and a most proximal electrode on each second spine is positioned at a lesser distance from the proximal stem, each microelectrode defining a concentricity, and the concentricities of the microelectrodes on one spine are different from the concentricities of microelectrodes on adjacent spines when the plurality of spines is in an expanded configuration. However, Just et al. disclose an electrophysiology catheter (catheter system 10; [0036]) comprising a plurality of microelectrodes (54) disposed on a plurality of spines (24, 124), the microelectrodes (54) arranged in a staggered configuration between the first spines (241, 1241) and the second spines (242, 1242), wherein a most proximal microelectrode (54p) on each first spine (241, 1241) is positioned at a greater distance from a proximal stem (shoulder portion 50; [0045]), and a most proximal electrode (54p) on each second spine (242, 1242) is positioned at a lesser distance from the proximal stem (50), each microelectrode (54) defining a concentricity, and the concentricities of the microelectrodes on one spine (242, 1242) are different from the concentricities of microelectrodes on adjacent spines (241, 1241) when the plurality of spines (24, 124) is in an expanded configuration ([0053-0055]; Fig. 10-11). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mest such that the microelectrodes are arranged in a staggered configuration between the first spines and the second spines, wherein a most proximal microelectrode on each first spine is positioned at a greater distance from the proximal stem, and a most proximal electrode on each second spine is positioned at a lesser distance from the proximal stem, each microelectrode defining a concentricity, and the concentricities of the microelectrodes on one spine are different from the concentricities of microelectrodes on adjacent spines when the plurality of spines is in an expanded configuration in order to provide the benefit of preventing short circuiting between adjacent spine electrodes in a collapsed or partially collapsed state as taught by Just et al. ([0053-0055]; Fig. 10-11)
While Mest discloses the distal end of the catheter (19) comprising three lumens (infusion lumen 30, lead wire lumen 34 & puller wire lumen 2; [0025]; Fig. 6), Mest in view of Just et al. fail to disclose an insert situated in the inner lumen of the proximal stem, the insert being shorter than the proximal stem and spaced apart proximally from the distal end of the proximal stem and the proximal ends of the plurality of spines, the insert including an outer surface smaller than the inner lumen of the proximal stem in defining a circumferential void between the inner lumen and the outer surface that is filled with an adhesive configured to secure the insert in a fixed relationship with the proximal stem, the insert configured with a second length along the longitudinal axis, the second length lesser than the first length of the proximal stem; the insert configured with at least one lumen, the plurality of lead wires and the elongated irrigation tubing extending through the at least one lumen. However, Diep et al. disclose an electrophysiology catheter (catheter 10; [0055]) comprising an insert situated in the inner lumen of the proximal stem (mounting ring inner tube 44 is secured within proximal mounting portion 62 of cylindrical body 63 of unibody support member 60; [0078], [0080], [0084]), the insert being shorter than the proximal stem and spaced apart proximally from the distal end of the proximal stem and the proximal ends of the plurality of spines (mounting ring inner tube 44 is shorter than proximal mounting portion 62 and is spaced apart proximally form the distal end 64 of within proximal mounting portion 62 and proximal ends of spines 24; Fig. 14), the insert including an outer surface smaller than the inner lumen of the proximal stem in defining a circumferential void between the inner lumen and the outer surface that is filled with an adhesive configured to secure the insert in a fixed relationship with the proximal stem (adhesive is disposed between mounting ring inner tube 44 and proximal mounting portion 62; Fig. 14), the insert configured with a second length along the longitudinal axis, the second length lesser than the first length of the proximal stem (mounting ring inner tube 44 is shorter than proximal mounting portion 62; Fig. 14); the insert configured with at least one lumen, the plurality of lead wires extending through the at least one lumen (mounting ring inner tube 44 comprises mounting ring lumen 46 through which electrode lead wires 29 extend; [0076]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mest in view of Just et al. to further comprise an insert situated in the inner lumen of the proximal stem, the insert being shorter than the proximal stem and spaced apart proximally from the distal end of the proximal stem and the proximal ends of the plurality of spines, the insert including an outer surface smaller than the inner lumen of the proximal stem in defining a circumferential void between the inner lumen and the outer surface that is filled with an adhesive configured to secure the insert in a fixed relationship with the proximal stem, the insert configured with a second length along the longitudinal axis, the second length lesser than the first length of the proximal stem; the insert configured with at least one lumen, the plurality of lead wires extending through the at least one lumen in order to provide the benefit of a mounting structure as taught by Diep et al. ([0074]) The modified invention of Mest in view of Diep et al. disclose the elongated irrigation tubing extending through the at least one lumen of the insert.
Concerning claim 10, as illustrated in at least Figs. 1-9, Mest discloses an electrophysiology catheter (catheter 10 can be used for electrophysiology; [0022]) comprising:
an elongated body defining a longitudinal axis (elongated catheter body 12; [0022]);
a distal electrode assembly distal of the elongated body (mapping assembly 15 mounted at the distal end of body 12; [0022]) and comprising:
a unibody support member (support structure 120 is manufactured from a single tube and has a unitary structure; [0059-0060]) including a proximal stem with a first length along the longitudinal axis (base 122 has a first length; [0059]), an inner lumen (interior or base 122 has an inner lumen), and a plurality of spines emanating from a distal end of the proximal stem (plurality of support arms 124 extending from the base; [0059]), the proximal stem configured to define a circumference around the longitudinal axis (base 122 defines a circumference around the longitudinal axis), and proximal ends of the plurality of spines extending from the distal end of the proximal stem and emanating from the circumference defined by the proximal stem (plurality of support arms 124 extending from the base; [0059]), each of the plurality of spines terminating in a free distal end (tips 127; [0061]);
a plurality of nonconductive spine covers, each spine cover surrounding a respective spine (each spine 118 comprises a support arm 124 and a non-conductive covering 134 in surrounding relation to the support arm 124; [0054]);
a plurality of microelectrodes carried on the spines (ring electrodes 125 are mounted on the non-conductive covering 134 of each spine 118; [0055]);
a plurality of lead wires, each connected to a respective microelectrode (each ring electrode 125 is electrically connected to an electrode lead wire 129; [0056]);
an elongated irrigation tubing extending through the elongated body and the proximal stem, the irrigation tubing including a distal end coextensive with the distal end of the proximal stem (infusion lumen 30 connected to needle electrode assembly 46 having distal tube 35 is used to inject saline or other fluid and is extendable and retractable, and may be moved by manipulation of the needle control handle 17 such that the distal end is coextensive with the distal end of base 122; [0035]).
Mest fails to disclose the microelectrodes arranged in a staggered configuration between adjacent ones of the plurality of spines, wherein a most proximal microelectrode on a first spine is positioned at a greater distance from the proximal stem, a most proximal electrode on an adjacent second spine is positioned at a lesser distance from the proximal stem, the microelectrodes on the first spine have a first separation distance from each other, and the microelectrodes on the second spine have a second separation distance from each other, wherein the first and second separation distances are different, each microelectrode defining a concentricity, and the concentricities of the microelectrodes on one spine are different from the concentricities of microelectrodes on adjacent spines when the plurality of spines is in an expanded configuration. However, Just et al. disclose an electrophysiology catheter (catheter system 10; [0036]) comprising a plurality of microelectrodes (54) disposed on a plurality of spines (24, 124), the microelectrodes (54) arranged in a staggered configuration between adjacent ones of the plurality of spines (24, 124), wherein a most proximal microelectrode (54p) on a first spine (241, 1241) is positioned at a greater distance from the proximal stem (shoulder portion 50; [0045]), a most proximal electrode (54p) on an adjacent second spine (242, 1242) is positioned at a lesser distance from the proximal stem (shoulder portion 50; [0045]), the microelectrodes (54) on the first spine (241, 1241) have a first separation distance (l) from each other, and the microelectrodes (54) on the second spine (242, 1242) have a second separation distance (l) from each other (spacing between electrodes 54 can vary based on the length of splines 241, 1241, 242, 1242or the desired distance from the proximal and distal ends 26, 28 of the splines 241, 1241, 242, 1242), wherein the first and second separation distances are different, each microelectrode (54) defining a concentricity, and the concentricities of the microelectrodes (54) on one spine (242, 1242) are different from the concentricities of microelectrodes on adjacent spines (241, 1241) when the plurality of spines (24, 124) is in an expanded configuration. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mest such that the microelectrodes arranged in a staggered configuration between adjacent ones of the plurality of spines, wherein a most proximal microelectrode on a first spine is positioned at a greater distance from the proximal stem, a most proximal electrode on an adjacent second spine is positioned at a lesser distance from the proximal stem, the microelectrodes on the first spine have a first separation distance from each other, and the microelectrodes on the second spine have a second separation distance from each other, wherein the first and second separation distances are different, each microelectrode defining a concentricity, and the concentricities of the microelectrodes on one spine are different from the concentricities of microelectrodes on adjacent spines when the plurality of spines is in an expanded configuration in order to provide the benefit of a desired electrode configuration and preventing short circuiting between adjacent spine electrodes in a collapsed or partially collapsed state as taught by Just et al. ([0053-0055]; Fig. 10-11)
While Mest discloses the distal end of the catheter (19) comprising three lumens (infusion lumen 30, lead wire lumen 34 & puller wire lumen 2; [0025]; Fig. 6), Mest in view of Just et al. fail to disclose an insert situated in the inner lumen of the proximal stem, the insert being shorter than the proximal stem and spaced apart proximally from the distal end of the proximal stem and the proximal ends of the plurality of spines, the insert including an outer surface smaller than the inner lumen of the proximal stem in defining a circumferential void between the inner lumen and the outer surface that is filled with an adhesive configured to secure the insert in a fixed relationship with the proximal stem, the insert configured with a second length along the longitudinal axis, the second length lesser than the first length of the proximal stem; the insert configured with at least one lumen, the plurality of lead wires and the elongated irrigation tubing extending through the at least one lumen. However, Diep et al. disclose an electrophysiology catheter (catheter 10; [0055]) comprising an insert situated in the inner lumen of the proximal stem (mounting ring inner tube 44 is secured within proximal mounting portion 62 of cylindrical body 63 of unibody support member 60; [0078], [0080], [0084]), the insert being shorter than the proximal stem and spaced apart proximally from the distal end of the proximal stem and the proximal ends of the plurality of spines (mounting ring inner tube 44 is shorter than proximal mounting portion 62 and is spaced apart proximally form the distal end 64 of within proximal mounting portion 62 and proximal ends of spines 24; Fig. 14), the insert including an outer surface smaller than the inner lumen of the proximal stem in defining a circumferential void between the inner lumen and the outer surface that is filled with an adhesive configured to secure the insert in a fixed relationship with the proximal stem (adhesive is disposed between mounting ring inner tube 44 and proximal mounting portion 62; Fig. 14), the insert configured with a second length along the longitudinal axis, the second length lesser than the first length of the proximal stem (mounting ring inner tube 44 is shorter than proximal mounting portion 62; Fig. 14); the insert configured with at least one lumen, the plurality of lead wires extending through the at least one lumen (mounting ring inner tube 44 comprises mounting ring lumen 46 through which electrode lead wires 29 extend; [0076]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mest in view of Just et al. to further comprise an insert situated in the inner lumen of the proximal stem, the insert being shorter than the proximal stem and spaced apart proximally from the distal end of the proximal stem and the proximal ends of the plurality of spines, the insert including an outer surface smaller than the inner lumen of the proximal stem in defining a circumferential void between the inner lumen and the outer surface that is filled with an adhesive configured to secure the insert in a fixed relationship with the proximal stem, the insert configured with a second length along the longitudinal axis, the second length lesser than the first length of the proximal stem; the insert configured with at least one lumen, the plurality of lead wires extending through the at least one lumen in order to provide the benefit of a mounting structure as taught by Diep et al. ([0074]) The modified invention of Mest in view of Diep et al. disclose the elongated irrigation tubing extending through the at least one lumen of the insert.
Concerning claims 2 & 11, Mest et al. disclose the distal electrode assembly comprises at least four first spines and four second spines for a total of at least eight spines ([0053]; Fig. 8). Mest in view of Just et al. and Diep et al. fail to specifically disclose each spine carries six microelectrodes. However, Mest et al. disclose each spine can have at least four ring electrodes, but fewer or additional ring electrodes may be used as desired ([0055]). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Mest in view of Just et al. and Diep et al. such that each spine carries six microelectrodes, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. See also In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Concerning claim 3, Just et al. further disclose the microelectrodes (54) on the first spine (241, 1241) have a first separation distance (l) from each other, and the microelectrodes (54) on the second spine (242, 1242) have a second separation distance (l) from each other, wherein the first (l) and second (l) separation distances are the same ([0053]).
Concerning claims 5-6 & 12-13, Mest in view of Just et al. and Diep et al. fail to specifically disclose the microelectrodes configured as either monopoles or dipoles. However, Diep et al. further disclose microelectrodes (28) that can be configured as monopoles or dipoles. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mest in view of Just et al. and Diep et al. such that the microelectrodes are configured as either monopoles or dipoles in order to provide the benefit of delivering energy in multiple modes as taught by Diep et al. ([0065], [0068]).
Claim(s) 7-8 & 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mest (2005/0090728) in view of Just et al. (2013/0172715) and Diep et al. (2014/0194716), as applied to claims 9 & 10, in further view of Oliverius et al. (2017/0319269).
Concerning claims 7 & 14, Mest in view of Just et al. and Diep et al. fail to disclose the adhesive adheres to a textured outer surface of the insert. However, Oliverius et al. teach an adhesive located between an insert (366) and a catheter shaft, where the insert (366) has a textured outer surface to provide an area for an adhesive to collect. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mest in view of Just et al. and Diep et al. such that the adhesive adheres to a textured outer surface of the insert in order to provide the benefit of providing an area for an adhesive to collect as taught by Oliverius et al. ([0108])
Concerning claims 8 & 15, Mest in view of Just et al. and Diep et al. fail to disclose the insert has a noncircular outer cross-section. However, Oliverius et al. teach an insert (366) within a catheter shaft, where the insert (366) has a has a noncircular outer cross-section to provide an area for an adhesive to collect. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mest in view of Just et al. and Diep et al. such that the adhesive adheres to a textured outer surface of the insert in order to provide the benefit of providing an area for an adhesive to collect as taught by Oliverius et al. ([0108]; Fig. 8A-F)
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mest (2005/0090728) in view of Just et al. (2013/0172715) and Diep et al. (2014/0194716), as applied to claims 9 & 10, in further view of Webster (5,782,239).
Concerning claims 16-19, Mest in view of Just et al. and Diep et al. fail to specifically disclose each of the plurality of spines has a unique staggered configuration of the microelectrodes, the spacing between adjacent microelectrodes along any one of the plurality of spines is nonuniform, the spacing between adjacent microelectrodes along any one of the plurality of spines is nonuniform, nor wherein at least one of the plurality of spines has a different number of microelectrodes than a different one of the plurality of spines. However, Webster teaches an electrophysiology catheter that comprises a plurality of spines (9) having a plurality of microelectrodes and teaches that the number and spacing of electrodes may vary as desired (Col. 5, ll. 1-6). It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Mest in view of Just et al. and Diep et al. such that each of the plurality of spines has a unique staggered configuration of the microelectrodes, the spacing between adjacent microelectrodes along any one of the plurality of spines is nonuniform, the spacing between adjacent microelectrodes along any one of the plurality of spines is nonuniform, nor wherein at least one of the plurality of spines has a different number of microelectrodes than a different one of the plurality of spines in order t provide the benefit of a number and spacing of electrodes as desired as taught by Webster et al.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mest (2005/0090728) in view of Just et al. (2013/0172715) and Diep et al. (2014/0194716), as applied to claims 9 & 10, in further view of Gelinas et al. (4,522,212).
Concerning claim 20, Mest in view of Just et al. and Diep et al. fail to disclose each of the plurality of spines comprises a proximal segment having a first preformed curvature C1 defined by a first radius R1, and a distal segment having a second preformed curvature C2 defined by a second radius R2, where the first radius R1 is lesser than the second radius R2, and the first and second curvatures R1 and R2 have generally opposing directions such that the plurality of spines defines a generally forward-facing concavity in a neutral configuration, and wherein the plurality of spines are configured to transition from the neutral configuration to a deformed configuration when the free distal ends of the spines contact tissue, the deformed configuration having a crouched generally forward-facing concavity. However Gelinas et al. disclose an electrode assembly for a catheter comprising a plurality of spines (legs) having a proximal segment having a first preformed curvature C1 (leg bending concavely outwardly from the nodal point N) defined by a first radius R1 (R1), and a distal segment having a second preformed curvature C2 (leg then bent convexly back) defined by a second radius R2 (R2), where the first radius R1 (R1) is lesser than the second radius R2 (R2), and the first and second curvatures R1 and R2 (R1, R2) have generally opposing directions such that the plurality of spines (legs) defines a generally forward-facing concavity in a neutral configuration, and wherein the plurality of spines are configured to transition from the neutral configuration to a deformed configuration when the free distal ends of the spines contact tissue, the deformed configuration having a crouched generally forward-facing concavity. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mest in view of Just et al. and Diep et al. such that the each of the plurality of spines comprises a proximal segment having a first preformed curvature C1 defined by a first radius R1, and a distal segment having a second preformed curvature C2 defined by a second radius R2, where the first radius R1 is lesser than the second radius R2, and the first and second curvatures R1 and R2 have generally opposing directions such that the plurality of spines defines a generally forward-facing concavity in a neutral configuration, and wherein the plurality of spines are configured to transition from the neutral configuration to a deformed configuration when the free distal ends of the spines contact tissue, the deformed configuration having a crouched generally forward-facing concavity in order to provide the benefit of providing a three dimensional array of electrode contact points with the tissue as taught by Gelinas et al. (Col. 2, ll. 17-43, Col. 5, ll. 8-17; Fig. 1-4)
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mest (2005/0090728) in view of Just et al. (2013/0172715) and Diep et al. (2014/0194716), as applied to claims 9 & 10, in further view of Basu et al. (2017/0224237).
Concerning claim 22, Mest in view of Just et al. and Diep et al. fail to disclose each of the plurality of spines comprises a proximal segment having a first preformed curvature CJ defined by a first radius RJ, a distal segment having a second preformed curvature CL defined by a second radius RL, and a middle segment that is generally linear, where the first radius RJ is lesser than the second radius RL, the plurality of spines defining a general concavity in a neutral configuration, and the plurality of spines are configured to transition from the neutral configuration to a deformed configuration when the free distal ends of the spines contact tissue, the deformed configuration having a lower profile compared to the neutral configuration. However Gelinas et al. disclose an electrode assembly (15) for a catheter (10) comprising a plurality of spines (42) a proximal segment having a first preformed curvature CJ (proximal curve bending proximally) defined by a first radius RJ, and a distal segment having a second preformed curvature CL (distal curve bending distally at location of reference numeral 85 in Fig. 1) defined by a second radius RL, where the first radius RJ is lesser than the second radius RL (first radius is lesser than the second), and the first and second curvatures RJ and RL have generally opposing directions such that the plurality of spines (42) defines a generally forward-facing concavity in a neutral configuration (distal electrode assembly 15 has a generally slightly concave configuration resembling an open umbrella; [0058]), and wherein the plurality of spines (42) are configured to transition from the neutral configuration to a deformed configuration when the free distal ends of the spines contact tissue, the deformed configuration having a crouched generally forward-facing concavity (spine 42 to engage tissue surface 93 generally along its entire length when catheter is advanced distally against tissue surface; [0058]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mest in view of Just et al. and Diep et al. such that the each of the plurality of spines comprises a proximal segment having a first preformed curvature CJ defined by a first radius RJ, a distal segment having a second preformed curvature CL defined by a second radius RL, and a middle segment that is generally linear, where the first radius RJ is lesser than the second radius RL, the plurality of spines defining a general concavity in a neutral configuration, and the plurality of spines are configured to transition from the neutral configuration to a deformed configuration when the free distal ends of the spines contact tissue, the deformed configuration having a lower profile compared to the neutral configuration in order to provide the benefit of enabling each spine to engage tissue surface along its entire length and avoiding flipping outwardly and losing tissue contact as the catheter is pushed distally against the tissue surface as taught by Basu et al. ([0058])
Allowable Subject Matter
Claim 21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination, teaches “wherein each of the plurality of spines comprises a proximal segment having a first preformed curvature CA defined by a first radius RA, a middle segment having a second preformed curvature CB defined by a second radius RB, and a distal segment that is generally linear, where the first radius RA is lesser than the second radius RB, the plurality of spines defining a general concavity in a neutral configuration, and the plurality of spines are configured to transition from the neutral configuration to a deformed configuration when the free distal ends of the spines contact tissue, the deformed configuration having a deeper concavity compared to the concavity of the neutral configuration.”
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Fang (2013/0253504) teaches pre-formed spines that are flat with no concavity in the neutral configuration (Fig. 6A-C & 13A-D). Whayne et al. (6,402,746) teaches spines with various curvatures (Fig. 56-58 & 61-63C). Swanson (7,806,893) teaches spines with various curvatures, with a first proximal radius of curvature being larger than a more distal radius of curvature separated by an intermediate linear segment (Fig. 6). Fuimaono et al. (2014/0194716) teach cup-shaped curvatures (Fig. 5).
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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