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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/11/2024 was filed after the mailing date of the application on 12/11/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,201,351 B2, herein after “Kim”.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application describes the same limitations as seen in Kim.
Regarding claim 1, the instant application recites “A catheter system comprising:
a guidewire lumen configured to accommodate a guidewire;
a coolant inlet lumen configured to allow the injection of coolant in the catheter system;
a coolant outlet lumen surrounding the coolant inlet lumen, wherein the coolant outlet lumen is configured to direct coolant flow backward after it enters through the coolant inlet lumen;
a partitioning structure between the guidewire lumen and the coolant outlet lumen to prevent communication between said lumens;
wherein coolant injected along the coolant inlet lumen flows backward along the coolant outlet lumen; and wherein the coolant inlet lumen is constructed to facilitate backward flow of coolant along the coolant outlet lumen, thereby providing a cooling effect”.
Claim 1 of Kim teaches “A RF catheter for septal reduction therapy, the RF catheter comprising: … a guidewire lumen… to allow a guidewire to be inserted… a coolant inlet lumen which is connected from a proximal part to an inner portion of the intra-septal part to allow a coolant to be injected from the outside and which has an open end, and a coolant outlet lumen which communicates with the coolant inlet lumen and has an exit formed in a side surface, wherein the intra-septal part penetrates the myocardium and inserted thereinto with guidance of the guidewire, and the coolant inlet lumen an open end, wherein the coolant outlet lumen has a structure surrounds the coolant inlet, wherein the guidewire lumen and the coolant inlet lumen do not communicate with each other and are partitioned from each other, wherein the guidewire lumen and the coolant outlet lumen do not communicate with each other and are partitioned from each other and the exit of the coolant outlet lumen is arranged to space apart from the outlet of the guidewire lumen; wherein the coolant outlet lumen has a structure that surrounds the coolant inlet lumen, and the coolant injected along the coolant inlet lumen flows backward along the coolant outlet lumen surrounding the coolant inlet lumen.” While these claims are not identical, the claims at issue are not patentably distinct from each other because the claims of Kim anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the patent claims (Kim). Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, application may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding claims 2-3, claim 1 is taught as described above. Claims 2-3 (“further comprising a distal portion” and “further comprising a body portion” are anticipated by claim 1 of Kim (“… the catheter comprising: … a distal part” and “… and a body part…”). While these claims are not identical, the claims at issue are not patentably distinct from each other because the claims of Kim anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the patent claims (Kim). Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, application may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding claim 4, the limitations of claim 2 are taught as described above. Claim 4 (“wherein the distal portion has a taped tip at the end thereof, and the tip tapers to become thinner toward its end to facilitate penetration into an interventricular septum and insertion therein”) is taught by claim 1 of Kim (“…an intra-septal part in which a tapered tip which becomes thinner toward an end thereof is formed at an end of a distal part to penetrate an interventricular septum and be inserted thereinto”). While these claims are not identical, the claims at issue are not patentably distinct from each other because the claims of Kim anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the patent claims (Kim). Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, application may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding claim 5, the limitations of claim 4 are taught as described above. Claim 5 (“wherein the distal portion has one or more electrodes formed on the outer circumferential surface of the distal portion, adjacent to the tip, for the purpose of delivering or sensing electrical signals”) is anticipated by claim 1 and 4 of Kim (“and in which one or more electrodes are formed at positions on an outer circumferential surface that are adjacent to the tip;” and “wherein the electrode is connected to a RF generator and serves to receive RF energy and emit the RF energy and serves to sense an electrical signal of the myocardium or apply electrical stimulation thereto”). While these claims are not identical, the claims at issue are not patentably distinct from each other because the claims of Kim anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the patent claims (Kim). Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, application may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding claim 6, the limitations of claim 3 are taught as described above. Claim 6 (“wherein the body portion comprises the guidewire lumen, the coolant inlet lumen, and the coolant outlet lumen”) is anticipated by claim 1 of Kim ( “…a body part which is made of a soft material and has a guidewire lumen which passes through the intra-septal part from the center of the end of the tip to allow a guidewire to be inserted and has an outlet formed in a side surface of the body part, a coolant inlet lumen which is connected from a proximal part to an inner portion of the intra-septal part to allow a coolant to be injected from the outside and which has an open end, and a coolant outlet lumen which communicates with the coolant inlet lumen and has an exit formed in a side surface”). While these claims are not identical, the claims at issue are not patentably distinct from each other because the claims of Kim anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the patent claims (Kim). Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, application may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding claim 7, the limitations of claim 5 are taught as described above. The limitations of claim 7 (“wherein a spiral coil wire or a braided wire is formed in the distal portion, and the wire is insulated from the electrode”) is taught by the limitations of claim 6 of Kim (“wherein a spiral coil wire or a braided wire is formed in the intra-septal part, and the wire is insulated from the electrode”). While these claims are not identical, the claims at issue are not patentably distinct from each other because the claims of Kim anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the patent claims (Kim). Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, application may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding claim 8, the limitations of claim 5 are taught as described above. Claim 8 (“wherein a hydrophilic polymer coating layer is applied to the surface of the distal portion, excluding the surface of the electrode”) is taught by claim 7 of Kim (“wherein, in the intra-septal part, a hydrophilic polymer coating layer is formed on a surface portion excluding a surface of the electrode”). While these claims are not identical, the claims at issue are not patentably distinct from each other because the claims of Kim anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the patent claims (Kim). Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, application may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding claim 9, the limitations of claim 5 are taught as described above. Claim 9 (“wherein an electrode wire configured to transmit RF energy to the electrode is covered by a sheath and spirally wrapped around the surface of the catheter, with as many electrode wires as the number of electrodes connected) is taught by claim 10 of Kim (“wherein an electrode wire configured to transmit RF energy to the electrode is covered with a sheath and spirally wrapped around a surface of the catheter, and as many electrode wires as the number of electrodes are connected”). While these claims are not identical, the claims at issue are not patentably distinct from each other because the claims of Kim anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the patent claims (Kim). Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, application may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding claim 10, the limitations of claim 5 are taught as described above. Claim 10 (“wherein, to measure the temperature of the electrode, at least two strands of a thermocouple wire are spirally wrapped around the surface of the catheter from the proximal to the distal portion, with both strands wound together”) are taught in claim 12 of Kim (“wherein, in order to measure the temperature of the electrode, two strands of a thermocouple wire are spirally wrapped around the surface of the catheter from the proximal part to the distal part while being wound together.”). While these claims are not identical, the claims at issue are not patentably distinct from each other because the claims of Kim anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the patent claims (Kim). Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, application may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding claim 11, the limitations of claim 10 are taught as described above. Claim 11 (“wherein one strand of the thermocouple wire is a nickel-chromium wire and the other strand is a nickel-alumel wire, both harmless to the human body”) is taught by claim 13 of Kim (“wherein one strand of the thermocouple wire is a nickel-chromium wire that is harmless to the human body, and the other strand of the thermocouple wire is a nickel-alumel wire that is harmless to the human body.”). While these claims are not identical, the claims at issue are not patentably distinct from each other because the claims of Kim anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the patent claims (Kim). Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, application may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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