DETAILED ACTION
This action is pursuant to the claims filed on 07/14/2026. Claims 2, 4-9, 12-24 are pending. A final action on the merits of claims 2, 4-9, 12-24 is as follows.
Response to Amendment
Applicant’s amendment to the claims are acknowledged and entered accordingly. As a result, the 112a rejections of the previous office action are withdrawn. Amendments similarly comply with the 112a requirements for the prior filed amendments, such that the effective filing date of the claims are 05/03/2016.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2, 4-7, 9, 12-15, 17-18, and 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,076,079. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims and/or amount to obvious variations of the reference claims.
Regarding claim 23, the reference patent recites the irrigation cross-over fluidly coupling the first and second connective stem members.
The reference patent fails to explicitly recite a first inlet manifold and the second a second inlet manifold of the corresponding first and second connective stem members that are coupled via the irrigation cross-over.
However, it would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to provide first and second inlet manifolds of the connective stem to be joined via the irrigation cross-over, since applicant has not disclosed that inlet manifolds solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any other configuration in which the irrigation cross-over connects the first and second connective stem members.
Regarding claim 24, the reference patent recites a first and second connective stem member that are assembled together.
The reference patent fails to explicitly recite wherein the first connective stem portion and the second connective stem portion are joined along a seam extending longitudinally along the connective stem.
However, it would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to provide the first and second connective stem portions to be joined along a seam extending longitudinally along the connective stem since applicant has not disclosed that the seam solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any other configuration in which the first and second stem members are joined together to function as recited.
Claims 8 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,076,079 in view of De La Rama (WO 2014/113612).
Regarding claim 8 and 20, De La Rama teaches a similar device wherein one or more electrodes configured for use in performing a position sensing function related to cardiac mapping (see at least abstract). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrodes of the reference patent in view of De La Rama to be used for cardiac mapping to arrive at claims 8 and 20 respectively. Cardiac mapping electrodes are well-known in the art to yield predictable results therein.
Claims 16, 19, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,076,079 in view of Kordis (U.S. Patent No. 5,904,680).
Regarding claim 16, Kordis teaches wherein the connective stem comprises circumferentially extending external ribs that are configured to reduce friction between the connective stem and the catheter shaft during insertion of the connective stem into the catheter shaft, and longitudinally spaced apart to accommodate adhesive therebetween to increase retention strength (Fig 30 Col 16 lines 23-32, anchor member 62 has ribs for friction fit). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connective stem of the reference patent in view of Kordis to incorporate ribs as claimed to reduce friction and longitudinally spaced to accommodate adhesive therebetween to arrive at claim 16. Doing so would be obvious to one of ordinary skill in the art as the use of circumferential ribs on a friction fitting as well as adhesive is well-known in the art to yield predictable results therein.
Regarding claim 19, Kordis teaches wherein the irrigated coupler includes one or more slots and the connective stem includes one or more stem keys couplable with the one or more slots (Fig 32 slots 66 of lock ring 64 correspond to stem keys 180 of splines). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connective stem and irrigated coupler of the reference patent in view of Kordis to incorporate slot and stem key coupling mechanism to arrive at claim 19. Doing so would be obvious to one of ordinary skill in the art as the use of a slot and stem key coupling mechanism is well-known in the art to yield predictable results therein.
Regarding claim 22, Kordis teaches wherein one of the first connective stem portion and the second connective stem portion comprises one or more longitudinal ridges and the other of the first connective stem portion and the second connective stem portion defines one or more longitudinal slots configured to receive the one or more longitudinal ridges to align the first connective stem portion and the second connective stem portion during assembly (Fig 32 slots 66 of lock ring 64 correspond to stem keys 180 of splines). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connective stem portions of the reference patent in view of Kordis to incorporate slot and ridges coupling mechanism to arrive at claim 22. Doing so would be obvious to one of ordinary skill in the art as the use of a slot and ridges coupling mechanism is well-known in the art to yield predictable results therein.
Claims 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,076,079 in view of Christian (U.S. PGPub No. 2014/0163548).
Regarding claim 21, Christian teaches wherein the connective stem defines a plurality of slots, wherein one or more wires are disposed in at least one of the plurality of slots and electrically coupled to the plurality of electrodes ([0040] core member 44 can include multiple lumens for receiving any number of components such as wires). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connective stem of the reference patent in view of Christian to incorporate the plurality of slots with one or more wires disposed in at least one slot to connect to the electrodes to arrive at claim 21. Doing so would be obvious to one of ordinary skill in the art as the use of a slot(s) for routing wire(s) is well-known in the art to yield predictable results therein.
Claims 2, 4-7, 9, 12-15, 17-18, and 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,540,876. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims and/or amount to obvious variations of the reference claims.
Regarding claim 23, the reference patent recites the irrigation cross-over fluidly coupling the first and second connective stem members.
The reference patent fails to explicitly recite a first inlet manifold and the second a second inlet manifold of the corresponding first and second connective stem members that are coupled via the irrigation cross-over.
However, it would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to provide first and second inlet manifolds of the connective stem to be joined via the irrigation cross-over, since applicant has not disclosed that inlet manifolds solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any other configuration in which the irrigation cross-over connects the first and second connective stem members.
Regarding claim 24, the reference patent recites a top and bottom connective stem member that are assembled together.
The reference patent fails to explicitly recite wherein the first connective stem portion and the second connective stem portion are joined along a seam extending longitudinally along the connective stem.
However, it would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to provide the first and second connective stem portions to be joined along a seam extending longitudinally along the connective stem since applicant has not disclosed that the seam solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any other configuration in which the first and second stem members are joined together to function as recited.
Claims 8 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,540,876 in view of De La Rama (WO 2014/113612).
Regarding claim 8 and 20, De La Rama teaches a similar device wherein one or more electrodes configured for use in performing a position sensing function related to cardiac mapping (see at least abstract). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrodes of the reference patent in view of De La Rama to be used for cardiac mapping to arrive at claims 8 and 20 respectively. Cardiac mapping electrodes are well-known in the art to yield predictable results therein.
Claims 16, 19, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,540,876 in view of Kordis (U.S. Patent No. 5,904,680).
Regarding claim 16, Kordis teaches wherein the connective stem comprises circumferentially extending external ribs that are configured to reduce friction between the connective stem and the catheter shaft during insertion of the connective stem into the catheter shaft, and longitudinally spaced apart to accommodate adhesive therebetween to increase retention strength (Fig 30 Col 16 lines 23-32, anchor member 62 has ribs for friction fit). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connective stem of the reference patent in view of Kordis to incorporate ribs as claimed to reduce friction and longitudinally spaced to accommodate adhesive therebetween to arrive at claim 16. Doing so would be obvious to one of ordinary skill in the art as the use of circumferential ribs on a friction fitting as well as adhesive is well-known in the art to yield predictable results therein.
Regarding claim 19, Kordis teaches wherein the irrigated coupler includes one or more slots and the connective stem includes one or more stem keys couplable with the one or more slots (Fig 32 slots 66 of lock ring 64 correspond to stem keys 180 of splines). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connective stem and irrigated coupler of the reference patent in view of Kordis to incorporate slot and stem key coupling mechanism to arrive at claim 19. Doing so would be obvious to one of ordinary skill in the art as the use of a slot and stem key coupling mechanism is well-known in the art to yield predictable results therein.
Regarding claim 22, Kordis teaches wherein one of the first connective stem portion and the second connective stem portion comprises one or more longitudinal ridges and the other of the first connective stem portion and the second connective stem portion defines one or more longitudinal slots configured to receive the one or more longitudinal ridges to align the first connective stem portion and the second connective stem portion during assembly (Fig 32 slots 66 of lock ring 64 correspond to stem keys 180 of splines). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connective stem portions of the reference patent in view of Kordis to incorporate slot and ridges coupling mechanism to arrive at claim 22. Doing so would be obvious to one of ordinary skill in the art as the use of a slot and ridges coupling mechanism is well-known in the art to yield predictable results therein.
Claims 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,540,876 in view of Christian (U.S. PGPub No. 2014/0163548).
Regarding claim 21, Christian teaches wherein the connective stem defines a plurality of slots, wherein one or more wires are disposed in at least one of the plurality of slots and electrically coupled to the plurality of electrodes ([0040] core member 44 can include multiple lumens for receiving any number of components such as wires). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connective stem of the reference patent in view of Christian to incorporate the plurality of slots with one or more wires disposed in at least one slot to connect to the electrodes to arrive at claim 21. Doing so would be obvious to one of ordinary skill in the art as the use of a slot(s) for routing wire(s) is well-known in the art to yield predictable results therein.
Allowable Subject Matter
Claims 2, 4-9, 12-24 are allowable over the prior art.
Regarding claims 2, 4-9, 12-24, the De La Rama (U.S. PGPub No. 2014/0200639), De La Rama-3 (WO 2014/113612), Potosky (U.S. PGPub No. 2017/0000980), Fang (U.S. PGPub No. 2013/0253504), De La Rama-2 (U.S. Patent No. 5,992,418), Christian (U.S. PGPub No. 2014/0163548), Donhowe (U.S. PGPub No. 2013/0096572), Kariv (U.S. PGPub No. 2014/0206985) references fail to teach “and a connective stem coupling the proximal end portion of the flexible tip assembly to the distal end of the catheter shaft, the connective stem comprising a first connective stem portion and a second connective stem portion, wherein the first connective stem portion and the second connective stem portion are separate components configured to be assembled together and coupled with the proximal end portion of the flexible tip assembly”. De La Rama-3 teaches a similar irrigated high density electrode catheter but fails to teach the first and second connective stem members being separate components that can be physically separated and assembled to form the connective stem among other limitations. De La Rama-2 appears to teach a similar connective stem having a top member and bottom member that are separate components (see Fig 4), however the top and bottom connective stem members of De La Rama-2 are not capable of being physically separated and assembled to form the connective stem. De La Rama similarly fails to cure the above noted deficiencies. The teachings of Christian, Donhowe, and Kariv fail to cure any of the above noted deficiencies. No other pertinent prior art reference were found that would overcome the above deficiencies. Therefore, there is no motivation (either in these references or elsewhere in the art) for making such specific and significant modifications thereto to arrive at claim(s) 2, 4-9, 12-24.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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