DETAILED ACTION
The following is a 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.
Response to Amendment
Acknowledgment is made to the amendment received 3/27/2026.
Applicant’s amendments to the drawings are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC 112(b)/second paragraph rejection set forth in the previous office action.
Claim Interpretation
Claims 1, 12 & 20 recites the limitation “a plurality of electrodes each coupled to one respective spine from a combined plurality of spines comprising the first plurality of spines and the second plurality spines”. Under BRI, this is interpreted as the plurality of electrodes being coupled to just one spine of the plurality of spines.
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) 1-5, 7-8, 10-17 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Litscher et al. (2015/0045788, previously cited) in view of Just et al. (2013/0172715) and Weber et al. (5,772,590, previously cited).
The Examiner notes that “opening” can be defined as “a gap, breach, or aperture” and “perimeter” can be defined as “a closed line bounding a plane area” (www.ahdictionary.com).
Concerning claim 1, as illustrated in at least Figs. 1 & 6A-D, Litscher et al. disclose an end effector of a catheter (distal energy delivery assembly 700 of a catheter; [0061]), the end effector comprising:
an expandable support frame assembly (distal energy delivery assembly 700 includes electrode cage 102 that expands away from a longitudinal axis to collectively form a basket shape; [0040], [0042], [0061]) comprising a first unitary structure (electrode tube 704; [0062]) and a second plurality of spines separate from each other and separate from the first unitary structure (separate electrode tube 702 has electrodes 706, 708 separate from each other at opposing bent ends 718, 720; [0062-0063]),
the first unitary structure comprising a distal hub and a first plurality of spines extending from the distal hub (electrode tube 704 has distal portion 732 with electrode spines 722, 724 extending therefrom; [0062]), the distal hub comprising a plurality of openings therethrough alternating in a circumferential direction with the first plurality of spines, a partial perimeter of each opening of the plurality of openings defined inward from an edge of the distal hub (distal portion 732 includes two corresponding notches alternating with spines 722, 724 in a circumferential direction around the distal portion 732 and having a partial perimeter defined inward from a distal most edge of the distal portion 732; [0063]), and
the second plurality of spines comprising respective distal portions coupled to the distal hub of the first unitary structure (opposing bends 718, 720 frictionally engaging distal portion 732 of electrode tube 704; [0063]), and each respective spine of the first plurality of spines and the second plurality of spines comprising a respective proximal end coupled together approximate a proximal end of the end effector (proximal portions 716, 730 are coupled to one another when assembled; [0062-0063]); and
a plurality of electrodes (electrode tube 702 includes two electrodes 706, 708 and electrode tube 704 includes electrodes 722, 724; [0062-0063]).
Litscher et al. fail to disclose the plurality of openings to comprise a full perimeter. However, Just et al. disclose an end effector (112) of a catheter comprising an expandable support assembly (122) and a distal hub (130) having a plurality of openings (134), each opening defining a full perimeter that is defined inward from a distal-most edge of the distal hub (130) and receives a distal end portion (128) of each of a plurality of splines (124) such that the spines (124) articulate to allow for increased distal flexibility of the expandable support structure (122), improved collapsibility of the expandable support structure (122), and decreased axial and radial resistive force which might otherwise result in failure at the distal end of end effector (112). 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 Litscher et al. such that the plurality of openings to comprise a full perimeter in order to provide the benefit of improved collapsibility of the expandable support structure (122), and decreased axial and radial resistive force which might otherwise result in failure at the distal end of the end effector as taught by Just et al. ([0047-0048]; Fig. 1-7) and since the partial perimeter openings of Litscher and the full perimeter openings of Just et al. are regarded as equivalents in the art for the purposes of providing flexibility of the spines to move between collapsed and expanded configurations.
Litscher et al. in view of Just et al. fail to disclose the plurality of electrodes each coupled to one respective spine from a combined plurality of spines comprising the first plurality of spines and of the second plurality of spines. However, Weber et al. disclose an end effector basket of a catheter comprising a plurality of spines (9) and a plurality of electrodes (11) that are either coupled to a respective spine (Fig. 2) or a plurality of electrodes (108) formed by removing insulation (106) from a conductive spine (102). 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 Litscher et al. in view of Just et al. such that the plurality of electrodes each coupled to one respective spine from a combined plurality of spines comprising the first plurality of spines and of the second plurality of spines since Weber et al. teach the equivalence of electrodes mounted on the spine and electrodes formed by the spine and removing insulation to be equivalents in the art for the purposes of treating tissue. (Col. 5, ll. 52-58, Col. 12, ll. 1-23; Fig. 1-2 & 15-16)
Concerning claim 2, Litscher et al. disclose the first plurality of spines (722, 724) and the second plurality of spines (706, 708) being configured to expand away from a longitudinal axis to collectively form a basket shape ([0040]).
Concerning claim 3, Litscher et al. disclose spines of the first plurality of spines (722, 724) being positioned in an alternating pattern with spines of the second plurality of spines (706, 708) (Fig. 6A-D).
Concerning claim 4, Litscher et al. disclose the first plurality of spines (722, 724) consisting of 2, 3, 4, 5, or 6 spines, and the second plurality of spines (706, 708) consisting of 2, 3, 4, 5, or 6 spines ([0047], [0062]; Fig. 6A-D).
Concerning claim 5, Litscher et al. disclose at least a portion of the spines of the second plurality of spines (706, 708) comprising a respective bend (718, 720) in a respective distal portion coupling, and the respective bend coupling (718, 720) the respective distal portion to the distal hub (732) ([0063]; Fig. 6A-D).
Concerning claim 7, Litscher et al. disclose respective distal portions (718, 720) of the second plurality of spines (706, 708) being disposed through respective openings of the plurality of openings of the distal hub (732) ([0063]; Fig. 6D).
Concerning claim 8, Litscher et al. disclose at least a portion of the spines of the second plurality of spines (706, 708) comprising a respective bend (718, 720) in the distal portion of a respective spine and approximate a respective opening of the plurality of openings (openings in circumferential outer surface) through which the respective spine extends such that the respective bend (718, 720) couples the distal portion of the respective spine to the distal hub (732) ([0063]; Fig. 6D).
Concerning claim 10, Litscher et al. disclose the first unitary structure (704) being constructed from a planar sheet and the distal hub (732) being substantially planar (when not assembled) ([0041], [0046], [0062], [0081]; Fig. 2A & 6A).
Concerning claim 11, Litscher et al. disclose the first unitary structure (704) being constructed from a tube (rolled panel) and the distal hub (732) being cylindrical ([0041], [0048], [0062]; Fig. 2A-B & 6A).
Concerning claim 12, as illustrated in at least Figs. 1-2H & 6A-D, Litscher et al. disclose an end effector of a catheter (distal energy delivery assembly 700 of a catheter; [0061]), the end effector comprising:
an expandable support frame assembly (distal energy delivery assembly 700 includes electrode cage 102 that expands away from a longitudinal axis to collectively form a basket shape; [0040], [0042], [0061]) comprising a first unitary structure (electrode tube 704; [0062]) and a second unitary structure separate from the first unitary structure (electrode 702 is separate from electrode tube 704; [0062]), the first unitary structure comprising a distal hub and a first plurality of spines extending from the distal hub (electrode tube 704 has distal portion 732 with electrode spines 722, 724 extending therefrom; [0062]), the distal hub comprising a plurality of openings therethrough alternating in a circumferential direction with the first plurality of spines, a partial perimeter of each opening of the plurality of openings defined inward from an edge of the distal hub (distal portion 732 includes two corresponding notches alternating with spines 722, 724 in a circumferential direction around the distal portion 732 and having a partial perimeter defined inward from a distal most edge of the distal portion 732; [0063]), and the second unitary structure comprising a second plurality of spines extending through one or more openings of the plurality of openings of the distal hub (electrode tube 702 has electrodes spines 706, 708 with distal opposing bends 718, 720 extending through openings of the circumferential surface of distal portion 730 of electrode tube 702; [0062]), and each respective spine of the first plurality of spines and the second plurality of spines comprising a respective proximal end coupled together approximate a proximal end of the end effector (proximal portions 718, 730 are coupled to one another when assembled; [0062-0063]); and
a plurality of electrodes (electrode tube 702 includes two electrodes 706, 708 and electrode tube 704 includes electrodes 722, 724; [0062-0063]).
Litscher et al. fail to disclose the plurality of openings to comprise a full perimeter. However, Just et al. disclose an end effector (112) of a catheter comprising an expandable support assembly (122) and a distal hub (130) having a plurality of openings (134), each opening defining a full perimeter that is defined inward from a distal-most edge of the distal hub (130) and receives a distal end portion (128) of each of a plurality of splines (124) such that the spines (124) articulate to allow for increased distal flexibility of the expandable support structure (122), improved collapsibility of the expandable support structure (122), and decreased axial and radial resistive force which might otherwise result in failure at the distal end of end effector (112). 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 Litscher et al. such that the plurality of openings to comprise a full perimeter in order to provide the benefit of improved collapsibility of the expandable support structure (122), and decreased axial and radial resistive force which might otherwise result in failure at the distal end of the end effector as taught by Just et al. ([0047-0048]; Fig. 1-7) and since the partial perimeter openings of Litscher and the full perimeter openings of Just et al. are regarded as equivalents in the art for the purposes of providing flexibility of the spines to move between collapsed and expanded configurations.
Litscher et al. in view of Just et al. fail to disclose the plurality of electrodes each coupled to one respective spine form a combined plurality of spines comprising the first plurality of spines and of the second plurality of spines. However, Weber et al. disclose an end effector basket of a catheter comprising a plurality of spines (9) and a plurality of electrodes (11) that are either coupled to a respective spine (Fig. 2) or a plurality of electrodes (108) formed by removing insulation (106) from a conductive spine (102). 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 Litscher et al. in view of Just et al. such that the plurality of electrodes each coupled to one respective spine form a combined plurality of spines comprising the first plurality of spines and of the second plurality of spines since Weber et al. teach the equivalence of electrodes mounted on the spine and electrodes formed by the spine and removing insulation to be equivalents in the art for the purposes of treating tissue. (Col. 5, ll. 52-58, Col. 12, ll. 1-23; Fig. 1-2 & 15-16)
Claim 13 is rejected upon the same rationale as applied to claim 2.
Claim 14 is rejected upon the same rationale as applied to claim 3.
Claim 15 is rejected upon the same rationale as applied to claim 4.
Claim 16 is rejected upon the same rationale as applied to claim 11.
Claim 17 is rejected upon the same rationale as applied to claim 10.
Concerning claim 20, as illustrated in at least Figs. 1-2H, Litscher et al. disclose a method of constructing a medical probe (methods for manufacturing and using catheters for applying energy to tissue; [0002]), the method comprising:
cutting a first unitary structure to form a hub, and a first plurality of spines extending from the hub; cutting one or more openings in the hub, a partial perimeter of each opening of the one or more openings defined inward form an edge of the hub and alternating circumferentially with the first plurality of spines (electrode panel 202 is formed from a planar sheet and longitudinal sections may be removed from between distal portion 22 and proximal portion 24 to form electrodes 10, 11 separated by longitudinal gap 18 and extending distal portion 22 that forms hub 22 having a central opening when rolled, where Litscher et al. also teach “those of ordinary skill in the art will understand that any of the examples disclosed herein may include one or more of the features discussed in connection with another of the other examples disclosed herein” in Par. [0041] such that electrode panels 702 & 704 may be formed similarly, where electrode tube 704 has distal portion 732 with electrode spines 722, 724 extending therefrom and distal portion 732 includes two corresponding notches alternating with spines 722, 724 in a circumferential direction around the distal portion 732 and having a partial perimeter defined inward from a distal most edge of the distal portion 732; [0041], [0047-0048], [0062-0063]);
cutting a second unitary structure to form a central portion and a second plurality of spines extending from central portion (electrode panel 203 is formed from a planar sheet and longitudinal sections may be removed from between distal portion 23 and proximal portion 25 to form electrodes 12, 13 separated by longitudinal gap 20, where in view of the teachings of Par. [0041], electrode panels 702 & 704 may be formed similarly, where electrode tube 702 has electrodes spines 706, 708 with distal opposing bends 718, 720 extending through openings of the circumferential surface of distal portion 730 of electrode tube 702 and central portion at proximal portion 716 that extends between spines 706, 708; [0041], [0047-0048], [0062]; [0047]);
extending at least a portion of the second plurality of spines through the one or more openings in the hub; positioning the central portion centrally with respect to the hub (when rolled, electrode panel 203/tube 205 has a radial profile and comprises electrode ribbons 12, 13 and central distal portion 23 such that it is received within opening of distal portion 22 of electrode panel 202 that forms tube 204 where in view of the teachings of Par. [0041], distal opposing bends 718, 720 extend through openings of the circumferential surface of distal portion 730 of electrode tube 702 and central portion at proximal portion 716 that extends between spines 706, 708 is positioned centrally with respect to the distal end 732 in the manner of the portion of 716 extending between 706, 708 is positioned towards the center of the distal end 732; [0047-0048], [0062-0063]);
affixing a respective proximal end of each spine of the first plurality of spines and the second plurality of spines at a distal end of an elongated shaft (proximal portions 24, 25 are coupled together, thereby affixing proximal ends of electrode ribbons 10-13, the proximal portions being located at a distal end of an elongated shaft of catheter 100, where in view of the teachings of Par. [0041], distal opposing bends 718, 720 extend through openings of the circumferential surface of distal portion 730 of electrode tube 702; [0047-0048], [0062-0063]).
Litscher et al. fail to disclose the plurality of openings to comprise a full perimeter. However, Just et al. disclose an end effector (112) of a catheter comprising an expandable support assembly (122) and a distal hub (130) having a plurality of openings (134), each opening defining a full perimeter that is defined inward from a distal-most edge of the distal hub (130) and receives a distal end portion (128) of each of a plurality of splines (124) such that the spines (124) articulate to allow for increased distal flexibility of the expandable support structure (122), improved collapsibility of the expandable support structure (122), and decreased axial and radial resistive force which might otherwise result in failure at the distal end of end effector (112). 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 Litscher et al. such that the plurality of openings to comprise a full perimeter in order to provide the benefit of improved collapsibility of the expandable support structure (122), and decreased axial and radial resistive force which might otherwise result in failure at the distal end of the end effector as taught by Just et al. ([0047-0048]; Fig. 1-7) and since the partial perimeter openings of Litscher and the full perimeter openings of Just et al. are regarded as equivalents in the art for providing the flexibility of the spines to move between collapsed and expanded configurations.
While Litscher et al. disclose the spines themselves to be electrodes, Litscher et al. in view of Just et al. fail to disclose the step of coupling a plurality of electrodes to spines of the first plurality of spines and the second plurality of spines. However, Weber et al. disclose an end effector basket of a catheter comprising a plurality of spines (9) and a plurality of electrodes (11) that are either coupled to a respective spine (Fig. 2) or a plurality of electrodes (108) formed by removing insulation (106) from a conductive spine (102). 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 Litscher et al. in view of Just et al. such that the plurality of electrodes coupled to a respective spine of the first plurality of spines and of the second plurality of spines since Weber et al. teach the equivalence of electrodes mounted on the spine and electrodes formed by the spine and removing insulation to be equivalents in the art for the purposes of treating tissue. (Col. 5, ll. 52-58, Col. 12, ll. 1-23; Fig. 1-2 & 15-16)
Claim(s) 6 & 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Litscher et al. (2015/0045788, previously cited) in view of Just et al. (2013/0172715) and Weber et al. (5,772,590, previously cited), as applied to claims 5 & 8, in further view of Marecki et al. (2015/0342491, previously cited).
Concerning claim 6, Litscher et al. in view of Just et al. and Weber et al. fail to disclose the respective bend being approximately 360 degrees. However, Marecki et al. disclose a basket end effector (320) comprising a plurality of spines (260) comprising a respective bend (298) in a respective distal portion to couple to a distal hub (270), the respective bend (298) being approximately 360 degrees (302). 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 Litscher et al. in view of Just et al. and Weber et al. such that the respective bend is approximately 360 degrees in order to provide the benefit of a locking element to ensure the spine is unable to be disengaged or removed from the distal hub opening as taught by Marecki et al. ([0082-0083; Fig. 8A-B & 9B)
Concerning claim 9, Litscher et al. in view of Just et al. and Weber et al. fail to disclose the respective bend being configured to rotate through the respective opening through which the respective spine extends. However, Marecki et al. disclose a basket end effector (320) comprising a plurality of spines (260) comprising a respective bend (298) in a respective distal portion to couple to a distal hub (270), the respective bend (298) being configured to rotate through a respective opening (274) through which a respective spine (260) extends. 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 Litscher et al. in view of Just et al. and Weber et al. such that the respective bend is configured to rotate through the respective opening through which the respective spine extends in order to provide the benefit of a locking element to ensure the spine is unable to be disengaged or removed from the distal hub opening as taught by Marecki et al. ([0082-0083; Fig. 8A-B & 9B)
Allowable Subject Matter
Claims 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art neither alone, nor in combination, discloses “the second unitary structure comprising a central portion circumscribed by the distal hub” in combination with the limitations of claim 19.
The Examiner notes the claim 19 was indicated allowable in the previous office action, but the amendments to the claims fail to include all the limitations of the allowable claim (including claims 17 & 18), and specifically the limitation reciting the central portion of the second unitary structure being “circumscribed” by the distal hub as recited in claim 18 in combination with the plurality of openings as recited in claim 19.
The Examiner further notes that claim 20 fails to recite the central portion to be “circumscribed by the distal hub”.
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
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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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794