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 .
Claim Objections
Claim 1 is objected to because of the following informalities: Line 15 of claim 1 recites “from the at least one spine, the electrode, the first electrically insulation portion, and the second electrically insulating portion being interlocked onto the at least one spine…”. It appear the first comma used should be a semi-colon in order to separate the next limitation from the previous one. Thus the claim should recite -- from the at least one spine[[,]] ; the electrode, the first electrically insulation portion, and the second electrically insulating portion being interlocked onto the at least one spine…. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-7, 9, 15, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being (a)(1) by Beeckler (US 2020/0205737 A1).
With regard to claim 1, Beeckler discloses A medical probe (shown in full in Fig. 1), comprising: a tubular shaft (29) having a proximal end (inherent) and a distal end (inherent), the tubular shaft extending along a longitudinal axis; and an expandable basket assembly (formed by splines 24) coupled to the distal end of the tubular shaft, the basket assembly comprising: at least one spine (24) extending along the longitudinal axis and configured to bow radially outward from the longitudinal axis when the expandable basket assembly is transitioned from a collapsed form to an expanded form (see Fig. 1); and a plurality of electrode assemblies (22, see also cross section in Fig. 2a, Section A-A and Fig. 2b), each electrode assembly of the plurality of electrode assemblies being attached to the at least one spine (24) and comprising: an electrode (36a and 36b); a first electrically insulating portion (30) electrically isolating the electrode from the at least one spine; and a second electrically insulating portion (50) electrically isolating the electrode from the at least one spine; the electrode, the first electrically insulating portion, and the second electrically insulating portion being interlocked onto the at least one spine such that the plurality of electrode assemblies are prevented from sliding proximally or distally along a length of the at least one spine (they are interlocked with the spine by the adhesive 46 and 48), with a first portion of each electrode assembly in the plurality of electrode assemblies being on a first side of the at least one spine (See the top surface or outer surface of the spine 24 where electrodes 36a and b are located), a second portion (51) of each electrode assembly in the plurality of electrode assemblies being on a second side of the at least one spine (the bottom or inner surface that faces the conduit 29) opposite the first side.
With regard to claim 2, Beeckler discloses wherein the at least one spine comprises a retainer ring (any of the adhesive layers can be considered a retaining ring 46/48/53) onto which a respective electrode assembly of the plurality of electrode assemblies is interlocked.
With regard to claim 3, Beeckler discloses wherein the electrode comprises a protrusion (43) configured to interlock with the second electrically insulating portion (it is interlocked with the second insulating layer 50 via adhesive 46).
With regard to claim 6, Beeckler discloses wherein: the first electrically insulating portion (30) comprises a first washer (Fig. 3 showing the assembly as a circular ring shape and thus portion 30 is considered a ring); and the second electrically insulating portion comprises a second washer (50, the assembly is a circular ring shape as shown in Fig. 3 and thus 48 is considered a washer).
With regard to claim 7, Beeckler discloses wherein the first washer (30) and the second washer (50) are configured to prevent the electrode from contacting the at least one spine (24) and to electrically isolate the electrode from the at least one spine.
With regard to claim 9, Beeckler discloses wherein: the first electrically insulating portion (30) comprises a first housing portion (30 can be considered a housing without any other additional structure to define the insulating portion); and the second electrically insulating portion (50) comprises a second housing portion (50 can be considered a housing without any other additional structure to define the insulating portion).
With regard to claim 10, Beeckler discloses wherein the first housing portion (30) and the second housing portion (50) are configured to interlock to secure the electrode to the at least one spine (the housing are configured to interlock because they are adhered via adhesive layers between them that secure the electrode).
With regard to claim 15, Beeckler discloses A method of constructing a medical probe, the method comprising: aligning an electrode (36a and b, see Fig. 1 and Fig. 2a and 2b), a first insulated portion (50), and a second insulated portion (55); placing a spine (24) of a basket catheter (29) between the first insulated portion and the second insulated portion (see Fig. 2a); and interlocking the electrode (interlocked via adhesives 46/48/53), the first insulated portion, and the second insulated portion together into an electrode assembly (22) to secure the electrode to the spine (via adhesives 46, 48, 53, shown in Fig. 2a) such that the first insulated portion and the second insulated portion electrically isolate the electrode from the spine (as shown in Fig.2a) and such that the electrode, the first insulated portion, and the second insulated portion are prevented from sliding proximally or distally along a length of the spine (because of the adhesive, the electrode, the first insulated portion and the second insulated portion are prevented from sliding) with a first portion of the electrode assembly (44, Fig. 2b) of the electrode assembly on a first side of the spine, and a second portion (51) of the electrode assembly on a second side of the spine opposite the first side.
With regard to claim 19, Beeckler discloses wherein: the first insulated portion comprises a first insulated housing portion (30 can be considered a housing without any other additional structure to define the insulating portion); and the second insulated portion comprises a second insulated housing portion (50 can be considered a housing without any other additional structure to define the insulating portion).
With regard to claim 20, Beeckler discloses wherein interlocking the electrode, the first insulated portion, and the second insulated portion together comprises interlocking the first insulated housing portion and the second insulated housing portion to thereby secure the electrode to the spine (the components are considered interlocked because they are adhered to one another via layers of adhesive).
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.
Claim(s) 4-5, 8,11-14, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beeckler (US 2020/0205737 A1) in view of Chou et al. (US 2015/0366508 A1).
With regard to claim 4, Beeckler discloses the claimed invention except for a protrusion of the electrode extending through the retainer ring.
Chou teaches a similar device (Fig. 9a) having a tubular shaft (114) and an expandable basket (110) and includes transducers (800/810) attached to spines (120) of the basket. While transducers are not exactly the same as electrodes, they are very similar structures that can be incorporated onto the spine in a similar manner. Chou teaches a transducer/electrode (804) with a first insulating portion (810) and a second insulating portion (812) and a retaining ring (814) the transducer/electrode having a protrusion (806) extending through the retainer ring (shown in Fig. 8) thereby preventing the electrode assembly from sliding along the length of the at least one spine (814 clamps down the assembly as shown in Fig. 8).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify assembly of Beeckler with the protrusion extending through the retainer ring as taught by Chou for the purpose of providing an alternative means of retaining the electrode assembly securely to the spine ([0134]).
With regard to claim 5, Beeckler discloses the protrusion (43) comprises a swage fitting (a swage fitting appears to simply be a shaped tool or die, and thus the protrusion of Beeckler can be considered a swage fitting without further definition of the protrusion).
With regard to claim 8, Beeckler discloses the claimed invention except for the second washer extending into the retainer ring.
Chou teaches wherein the second washer (812) comprises a lip (the open edge of 812 that fits over the electrode is considered a lip) configured to extend inwardly into a retainer ring (814) of the at least one spine to prevent the electrode from contacting the at least one spine (shown in Fig. 8).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify assembly of Beeckler with the lip of the second washer extending through the retainer ring as taught by Chou for the purpose of providing an alternative means of retaining the electrode assembly securely to the spine ([0134]).
With regard to claim 11, Beeckler discloses the claimed invention except for a male and female connector.
Chou teaches wherein: the second housing portion comprises a male connector (812); and the first housing portion comprises a female connector (810) configured receive the male connector and facilitate the first housing portion to interlock with the second housing portion.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify assembly of Beeckler with the female and male connector as taught by Chou for the purpose of surrounding and securing the electrode ([0134]).
With regard to claim 12, Beeckler discloses the claimed invention except for a rim.
Chou teaches the first housing (810) comprising a rim (810 is a tube and thus the end of the tube is considered a rim) configured to receive the electrode (as shown in Fig. 8).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify assembly of Beeckler with the rim as taught by Chou for the purpose of surrounding and securing the electrode ([0134]).
With regard to claim 13, Beeckler discloses the claimed invention except for a base portion.
Chou teaches the electrode further comprising a base portion (850) configured to retain the electrode in the rim of the first housing portion (Fig. 3).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify assembly of Beeckler with the base portion as taught by Chou for the purpose of assisting in retaining the electrode onto the spine ([0024]).
With regard to claim 14, Beeckler discloses the claimed invention except for the base portion.
Chou teaches wherein the base portion (850) comprises an outer perimeter length that is greater than an inner perimeter length of the rim (base 85 has a larger circumference than the lip or the round housing 810 and thus has an outer perimeter length that is greater).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify assembly of Beeckler with the base portion as taught by Chou for the purpose of assisting in retaining the electrode onto the spine ([0024]).
With regard to claim 16, Beeckler discloses the claimed invention except for a portion that extends through an aperture of the retainer ring.
Chou teaches the electrode (804), the first insulated portion (810), and the second insulated portion (812) together comprises interlocking a portion of at least one of the electrode, the first insulated portion, and the second insulated portion thorough an aperture of a retainer ring of the spine (retainer ring is formed by the four 814 posts such that the each of the electrode, the first and second housing are placed within the opening formed by the ring 814 to clamp the components together as shown in Fig. 8). It appears if the claims were to further define how the components are interlocked, this may help to overcome the current rejection.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify assembly of Beeckler with the interlocked components as taught by Chou for the purpose of securing all the components to the spine ([0134]).
With regard to claim 17, Beeckler discloses the claimed invention except for a retainer ring.
Chou teaches aligning the electrode (804), the first insulated portion (810) and the second insulated portion (812) with the retainer ring (814), see fully clamped assembly in Fig. 8.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify assembly of Beeckler with the interlocked components as taught by Chou for the purpose of securing all the components to the spine ([0134]).
With regard to claim 18, Beeckler discloses wherein interlocking the electrode, the first insulated portion, and the second insulated portion together comprises interlocking a protrusion of the electrode with the second insulated portion (protrusion of election 43) is interlocked with the second insulated portion (50) by adhesive 48).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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.
Applicant’s remarks with regard to the use of Fig. 3 in Beeckler is persuasive and this embodiment is no longer being used to teach the claimed invention. However, Beeckler Fig. 1, 2a and 2b does still teach the invention as claimed (see amended rejection of claim 1 and 15) and further structure or limitations regarding the first and second portion would need to be recited in order to overcome the current rejection.
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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/Lauren P Farrar/Primary Examiner, Art Unit 3783