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 April 21, 2026 have been entered. Applicant’s amendments have overcome the Drawing objection, the Specification objection, and the 112(a) rejection previously set-forth in the Non-Final Office Action mailed on 02/06/2026. Currently, claims 1, 6-7, 9-10, and 17 have been amended, claim 21 has been newly added, and claims 1-21 are pending in the application.
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.
Claim 17 is 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 17 recites the limitation "a respective spine proximal" in lines 3-4. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this respective spine proximal is different from the respective spine proximal end recited later on in the claim, or if they are the same structure. For examination purposes, Examiner will treat both as being the same structure on the end effector.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 6, 10-12, 16-18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Marrs (U.S. Application No. 20170065227 A1), and further in view of Schneider (U.S. Application No. 20200155194 A1).
Regarding independent claim 1, Marrs discloses a multi-piece framework for an end effector (12) for a medical device (10) (pa. 0051 & Figs. 1-2), the end effector comprising:
a distal end comprising a crown (28) (pa. 0053) extending along a longitudinal axis (24), defining a crown lumen (104) (pa. 0060), and defining a plurality of crown recesses (118 a 1-d 2) (pa. 0061 & Fig. 10A) configured to connect to an annulus (26) (pa. 0056 & Figs. 4-5B). Examiner is interpreting the word “connect to” as bringing together/two objects touching, either directly or indirectly. In this case, the annulus is brought together/connected to the inner surfaces of the crown, as illustrated in Fig. 26, where the side walls of the annulus touch at least a portion of the crown recesses; and
a plurality of spines (30 a-d) extending along the longitudinal axis and configured to bow outwardly relative to the longitudinal axis (pa. 0053), each spine extending from the crown to a spine proximal end (130 a) (pa. 0064 & Fig. 11), each spine proximal end comprising:
a first spine recess (140 a) defined in a first lateral side (164 a) of the spine proximal end (pa. 0065 & Fig. 15); and
a second spine recess (146 a) defined in a second lateral side (166 a) of the spine proximal end that is opposite the first lateral side (pa. 0065),
the first spine recess and the second spine recess being configured to interface with a connecting hub (32, specifically a combination of retainer ring 186, constraining ring 182, and torsion ring 184) (pa. 0053, 0068 & Fig. 17).
However, Marrs does not disclose the end effector being a monolithic framework comprising cylindrical stock.
Examiner will be interpreting the traditional phrase ”comprising” as synonymous with "including," "containing," or "characterized by," and as being inclusive or open-ended and not excluding additional, unrecited elements or method steps. See MPEP 2111.01.
Schneider, in the same field of endeavor, teaches a catheter (10) including an end effector (12) comprising a tubular body (32) being made up of a plurality of spines (34) and a crown (42) (pa. 0114), wherein the tubular body and the crown can be a single, one-piece component that is integrally, monolithically formed from a single piece of material, such as a sheet stock. In other examples, the tubular body and the crown can be formed separately and secured to one another in any suitable way (pa. 0114 & Fig. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the multiple-piece manufacturing method of the medical device of Marrs to be a single piece, monolithic framework as taught by Schneider, since either manufacturing technique would yield the same predictable results of creating an end effector with a plurality of splines with a crown.
Regarding claim 2, Marrs discloses the invention substantially as claimed in claim 1 discussed above.
However, Marrs does not disclose the monolithic framework consisting essentially of the cylindrical stock.
Examiner will be interpreting the traditional phrase “consisting essentially of” more narrowly than “comprising”, as described in claim 1, wherein “consisting essentially of” limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. See MPEP 2111.03.
Schneider, in the same field of endeavor, teaches a catheter (10) including an end effector (12) comprising a tubular body (32) being made up of a plurality of spines (34) and a crown (42) (pa. 0114), wherein the tubular body and the crown can be a single, one-piece component that is integrally, monolithically formed from a single piece of material, such as a sheet stock. In other examples, the tubular body and the crown can be formed separately and secured to one another in any suitable way (pa. 0114 & Fig. 3). Therefore, the Schneider reference teaches the end effector consisting essentially of a single piece of sheet stock. This is in-line with the filed Specification [pa. 050] which describes the framework 104 can be formed from a planar or cylindrical tube stock of material using any suitable method.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the multiple-piece manufacturing method of the medical device of Marrs to be a single piece, monolithic framework as taught by Schneider, since either manufacturing technique would yield the same predictable results of creating an end effector with a plurality of splines with a crown.
Regarding claims 6 and 21, Marrs/Schneider combination discloses each spine proximal end comprising:
a first set of spine recesses comprising the first spine recess and a third spine recess (144 a) defined in the first lateral side of the spine proximal end (Marrs, pa. 0065 & Fig. 15); and
a second set of spine recesses comprising the second spine recess and a fourth spine recess (142 a) defined in the second lateral side of the spine proximal end (Marrs, pa. 0065).
Regarding independent claim 10, Marrs discloses an end effector (12) for a medical device (10) (pa. 0051 & Figs. 1-2), the end effector comprising:
a multi-piece framework comprising:
a distal end comprising a crown (28) (pa. 0053) extending along a longitudinal axis (24) and defining a plurality of crown recesses (118 a 1-d 2) (pa. 0061 & Fig. 10A); and
a plurality of spines (30 a-d) extending along the longitudinal axis and configured to bow outwardly relative to the longitudinal axis (pa. 0053), the plurality of spines being movable between a collapsed configuration and an expanded configuration (pa. 0053), each spine extending from the crown to a spine proximal end (130 a) (pa. 0064 & Fig. 11), each spine proximal end comprising:
a first spine recess (140 a) defined in a first lateral side (164 a) of the spine proximal end (pa. 0065 & Fig. 15); and
a second spine recess (146 a) defined in a second lateral side (166 a) of the spine proximal end that is opposite the first lateral side (pa. 0065);
an annulus (26) connected to the plurality of crown recesses (pa. 0056 & Figs. 4-5B). Examiner is interpreting the word “connected to” as bringing together/two objects touching, either directly or indirectly. In this case, the annulus is brought together to the inner surfaces of the crown, as illustrated in Fig. 26, where the side walls of the annulus touch at least a portion of the crown recesses;
a connecting hub (32, specifically a combination of retainer ring 186, constraining ring 182, and torsion ring 184) (pa. 0068) connected to the plurality of spines such that the first spine recess and the second spine recess interfaces with the connecting hub (pa. 0053 & Fig. 17); and
one or more electrodes (40) connected to each spine of the plurality of spines (pa. 0055 & Fig. 3).
However, Marrs does not disclose the end effector being a monolithic framework comprising cylindrical stock.
Schneider, in the same field of endeavor, teaches a catheter (10) including an end effector (12) comprising a tubular body (32) being made up of a plurality of spines (34) and a crown (42) (pa. 0114), wherein the tubular body and the crown can be a single, one-piece component that is integrally, monolithically formed from a single piece of material, such as a sheet stock. In other examples, the tubular body and the crown can be formed separately and secured to one another in any suitable way (pa. 0114 & Fig. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the multiple-piece manufacturing method of the medical device of Marrs to be a single piece, monolithic framework as taught by Schneider, since either manufacturing technique would yield the same predictable results of creating an end effector with a plurality of splines with a crown.
Regarding claim 11, Marrs/Schneider combination discloses the crown defining a crown lumen (104), and the annulus extending through the crown lumen (Marrs, pa. 0060 & Fig. 9).
Regarding claim 12, Marrs/Schneider combination discloses the annulus comprising an atraumatic tip portion (58), a polygonal portion (combination of a cylindrical portion 64 and tapered portion 66) frictionally engaging an inner surface of the crown, and a tube portion (Marrs, pa. 0056-0057 & Figs. 7 and 26).
Regarding claim 16, Marrs/Schneider combination discloses further comprising a connector tube (46) extending generally parallel to or coaxial with the longitudinal axis and connected to the annulus (Marrs, pa. 0054, 0056).
Regarding claim 17, Marrs/Schneider combination discloses the connecting hub defining a plurality of hub reliefs (194 a 1-d 2, , 206 a 1-d 2), each hub relief being shaped to correspond to a shape of a respective spine proximal so as to receive the respective spine proximal end (Marrs, pa. 0069, 0071 & Figs. 17-23).
Regarding claim 18, Marrs/Schneider combination discloses the plurality of spines comprising a generally spheroidal shape when in the collapsed configuration (Marrs, pa. 0053).
Claims 3-4, 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Marrs and Schneider as applied to claims 1 and 10 above, and further in view of Conlon (W.O. Application No. 2017066087 A1).
Regarding claim 3, Marrs/Schneider combination discloses a crown terminal end (Marrs, i.e., bottom/lower section where circumferential wall 106 is located in Fig. 10A).
However, they do not disclose each crown recess comprising a first portion defined in the crown terminal end and extending parallel to the longitudinal axis, nor a second portion extending from and generally perpendicular to the first portion.
Conlon, in the same field of endeavor, teaches a medical assembly (3710) comprising a first coupling member (3010) (analogous to the annulus) and second coupling member (3730) (analogous to the crown) (pa. 000345-000346 & Figs. 103-106). The first coupling member comprises a plurality of bayonet mount tabs (3014) (pa. 000345, 000348), and the second coupling member comprises a plurality of bayonet slots (3732) (analogous to the crown recess) (pa. 000349), wherein the bayonet mount tabs rotatably engage the bayonet slots in a nonpermanent locking fashion, as demonstrated in Figs. 107A-107E). The plurality of bayonet slots further comprise a longitudinally extending portions (3736) (i.e., a first portion defined in a crown terminal end and extending parallel to the longitudinal axis) and angularly extending portions (3738) (i.e., a second portion extending from and generally perpendicular to the first portion) (pa. 000349).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the bayonet mount tabs of Conlon to the annulus of Marrs and to have added additional crown recesses (i.e., the bayonet slots of Conlon) to the crown terminal end of Marrs for the purpose of providing an additional method of frictionally securing these two elements together.
Regarding claim 4, Marrs/Schneider/Conlon combination discloses a plurality of crown holes (defined by screws which extend through circumferential wall 110 of crown 28 into cylindrical portion 64 of annulus 26 used to retain the crown and the annulus) extending generally perpendicular to the longitudinal axis (see Fig. 26), each crown hole being located between adjacent recesses of the plurality of crown recesses (Marrs, pa. 0075).
Regarding claim 13, Marrs/Schneider combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose the polygonal portion comprising a plurality of locking protrusions protruding radially outwards away from the longitudinal axis, each locking protrusion engaging in a respective crown recess of the plurality of crown recesses.
Conlon, in the same field of endeavor, teaches a medical assembly (3710) comprising a first coupling member (3010) (analogous to the annulus) and second coupling member (3730) (analogous to the crown) (pa. 000345-000346 & Figs. 103-106). The first coupling member comprises a plurality of bayonet mount tabs (3014) (i.e., a plurality of locking protrusions protruding radially outwards away from the longitudinal axis) (pa. 000345, 000348), and the second coupling member comprises a plurality of bayonet slots (3732) (analogous to the crown recess) (pa. 000349), wherein the bayonet mount tabs rotatably engage the bayonet slots in a nonpermanent locking fashion, as demonstrated in Figs. 107A-107E).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the bayonet mount tabs of Conlon to the annulus of Marrs and to have added the additional crown recesses (i.e., the bayonet slots of Conlon) to the crown of Marrs for the purpose of providing an additional method of frictionally securing these two elements together.
Regarding claim 14, Marrs/Schneider/Conlon combination discloses the polygonal portion defining a plurality of annulus holes (defined by screws which extend through circumferential wall 110 of crown 28 into cylindrical portion 64 of annulus 26 used to retain the crown and the annulus), each annulus hole being positioned proximal a respective locking protrusion of the plurality of locking protrusions (Marrs, pa. 0075). Examiner is interpreting the term proximal as being in a location closer to the operator or as being adjacent to, as described in the Specification of the instant application pa. 0057.
Regarding claim 15, Marrs/Schneider/Conlon combination discloses the crown defining a plurality of crown holes extending perpendicular to the longitudinal axis (the screws may extend through circumferential wall 110 of the crown 28 into the polygonal portion 64 of annulus 26), each crown hole axially aligning with a respective annulus hole of the plurality of annulus holes (Marrs, pa. 0075 & Fig. 26).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Marrs and Schneider as applied to claim 1 above, and further in view of Marecki (U.S. Application No. 20150342491 A1).
Regarding claim 7, Marrs/Schneider combination discloses the connecting hub (32) including the retainer ring (186), wherein the retainer ring comprises a plurality of apertures (222) which may be configured to be filled with epoxy or adhesive to allow for greater bond strength (Marrs, pa. 0073 & Fig. 17).
However, they do not disclose each spine proximal end defining at least one spine hole defined through the spine proximal end and extending perpendicular to the longitudinal axis, the at least one spine hole being positioned between the first set of spine recesses and the second set of spine recesses.
Marecki, in the same field of endeavor, teaches an electrode assembly catheter (30) comprising a plurality or splines (60, 160) (see Fig. 3B), wherein a terminal end of each splines comprises a locking feature (198) defined by a geometrical shape having a first portion (202) and a second portion (204) (the first and second portions being analogous to the spine recesses of Marrs) located on both lateral sides of each splines, and an aperture (201), extending perpendicular to a longitudinal axis and positioned between the first and second portions, that is filled with adhesive in order to provide further means of securing the terminal ends to a cap (pa. 0074 & Figs. 5A-5B).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the aperture of Marecki to each of the spines proximal end of Marrs in order to provide further means of securing the proximal ends of the spines to the connecting hub (Marecki, pa. 0074 & Figs. 5A-5B).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Marrs and Schneider as applied to claim 1 above, and further in view of Kordis (U.S. Application No. 20120271140 A1).
Regarding claim 8, Marrs/Schneider combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose each spine comprising a first arcuate bend, proximal the crown, in a first radial direction perpendicular to the longitudinal axis, nor a second arcuate bend, extending from the first arcuate bend, in a second radial direction perpendicular to the longitudinal axis.
Kordis, in the same field of endeavor, teaches a catheter assembly (8) including a spline basket (12) comprising a plurality of splines (14) (pa. 0103 & Figs. 1, 7), wherein each spine comprises a first arcuate bend (78) (pa. 0116 & Fig. 14), proximal the crown/distal tip (66), in a first radial direction (i.e., clockwise) perpendicular to the longitudinal axis, a second arcuate bend (see annotated Fig. 12 below), extending from the first arcuate bend, in a second radial direction (i.e., counterclockwise) perpendicular to the longitudinal axis.
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the plurality of spines of Marrs with the shape of each of the spines taught by Kordis for the purpose of allowing more control of the bending/collapsing of the spines (Kordis, pa. 0116).
Regarding claim 9, Marrs/Schneider combination discloses the invention substantially as claimed in claims 1 and 8 discussed above.
However, they do not disclose each spine comprising a third arcuate bend, distal to the spine proximal end and extending from the second arcuate bend, in the first radial direction.
Kordis, in the same field of endeavor, teaches each spine comprising a third arcuate bend (82) (pa. 0117 & Fig. 15), distal to the spine proximal end and extending from the second arcuate bend, in the first radial direction (see Fig. 12).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the plurality of spines of Marrs with the shape of each of the spines taught by Kordis for the purpose of providing added flexibility to the spines to better conform to the contours of the targeted tissue (Kordis, pa. 0117).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Marrs and Schneider as applied to claims 10 and 18 above, and further in view of Olson (U.S. Application No. 20200375657 A1).
Regarding claim 19, Marrs/Schneider combination discloses each spine of the plurality of spines having a proximal half (i.e., bottom-most half) and a distal half (i.e., top half including a middle section), and the plurality of electrodes being distributed on both halves (Marrs, see Fig. 3).
However, they do not disclose the one or more electrodes being disposed on only the distal half.
Olson, in the same field of endeavor, teaches a catheter (60A) comprising an expandable basket (62A) comprising a plurality of splines (66A) and electrodes (70B) (pa. 0046 & Fig. 3A), wherein the electrodes may be distributed along each spline in a variety of ways, one such method including the electrodes located on only the distal and equatorial portions of the spline (pa. 0050).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of the electrodes on the splines of Marrs since this specific distribution pattern of electrodes on the splines can be used to accommodate specific physiological features in a body (Olson, pa. 0050).
Response to Arguments
Applicant's arguments filed 04/21/2026 have been fully considered but they are not persuasive.
With regards to independent claims 1 and 10, Applicant argues that the Marrs reference does not disclose, “each spine proximal end comprising: a first spine recess defined in a first lateral side of the spine proximal end; and a second spine recess defined in a second lateral side of the spine proximal end that is opposite the first lateral side”. Specifically, Applicant contends that Marrs only discloses spine recesses on different proximal portions of each of the spines. However, Examiner, respectfully, disagrees.
The claim language of independent claims 1 and 10 are broad and only requires that each spine proximal end comprises a first spine recess defined in a first lateral side of the spine proximal end and a second spine recess defined in a second lateral side of the spine proximal end that is opposite the first lateral side. Hence, the claim limitation does not require that the first lateral side and the second lateral side be radially aligned along the proximal end of each spine. Therefore, as long as the prior art reference discloses a spine proximal end comprising bilateral spine recesses, even if they are not mirroring/aligned to each over in a certain axis, it would meet the claim limitations. Therefore, the rejection using the Marrs reference in view of Schneider is maintained.
With regards to claims 3-4, 13-15 unpatentable over Marrs in view of Schneider, and further in view Conlon. Examiner finds these arguments unpersuasive for the reasonings described above.
With regards to claim 7 unpatentable over Marrs in view of Schneider, and further in view of Marecki, Applicant argues that Marecki only teaches flexible spines 160 that "extend from a proximal band 186 to which they are attached or integrally formed with at their proximal ends 196", but lacks any recesses at proximal ends of the spines 160. Examiner disagrees.
The Marecki reference teaches a distal end of the spine comprising a locking feature (198) defined by a geometrical shape having a first portion (202) and a second portion (204) (the first and second portions being analogous to the spine recesses of Marrs) located on both lateral sides of each splines, and an aperture (201), extending perpendicular to a longitudinal axis and positioned between the first and second portions (pa. 0074 & Figs. 5A-5B). Examiner only relies on the aperture feature taught by Marecki, which is located on a spine terminal end (regardless if it on the distal end), because the combination described above only combines this aperture feature to the proximal end of the spines of Marrs in order to secure the spine proximal end to the connecting hub. Therefore, the rejection using the combination of references cited is maintained for the reasons describes 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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