DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) 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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 6, and 9 of U.S. Patent No. 11052188 in view of Ackermann (see table below).
Regarding claims 1 and 16, claim 1 of the issued patent claims all of the claimed limitations set forth in instant claims 1 and 16 except that proximal connector is a triple connector connected to the proximal section of the shaft and the infusion inlet is located in the connector.
Ackermann teaches an infusion inlet (see above) located in a triple connector connected to the proximal section of the shaft (manifold 600’ in fig. 6). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the issued claim so that the infusion inlet is located in a triple connector connected to the proximal section of the shaft since Ackermann teaches this configuration allows a fluid source to be coupled to the catheter for transport from the source, through the infusion inlet and out the infusion outlet for delivery to the targeted area and allows for easy connection to sources of inflation fluid and medicament while also allow delivery of a guidewire (paragraph 53).
Instant Claims
Patent Claims
Teaching
1
1
See discussion above
2
2
Claim 2 of the issued patent does not claim the inflation inlet is located in the proximal connector and the inflation outlet opens to an inner volume of the inflatable member. Ackermann teaches the inflation inlet is located in the proximal connector (see annotated figure above) and the inflation outlet opens to an inner volume of the inflatable member (fig. 1 shows the outlet of lumen 130 opening to balloon 410). Therefore, it would have been obvious to have modified the issued claim to have the claimed features for allowing inflation fluid to travel from an inflation source to the inflatable member for inflation.
3
Ackermann teaches the inflation inlet and the inflation outlet are different from the infusion inlet and the infusion outlet (see annotated figure above and infusion outlet 310a and the outlet of lumen 130 in fig. 1). Therefore, it would have been obvious to have modified the issued patent with the claimed features to allow for the introduction of separate infusion and inflation fluids.
4
Ackermann teaches a proximal guidewire opening is located in the proximal connector (see annotated figure above) and a distal guidewire opening is located in the distal section of the shaft (160 in fig. 1), wherein the proximal guidewire opening and the distal guidewire opening are configured to allow passage of the guidewire (fig. 1). Therefore, it would have been obvious to have modified the issued claim with the claimed features for the purpose enabling a guidewire to pass through the catheter to assist in placing the catheter within the body, as known in the art.
5
Ackermann teaches the proximal guidewire opening and the distal guidewire opening are different from the infusion inlet and the infusion outlet (see annotated figure above and fig. 1). Therefore, it would have been obvious to have modified the issued claim for the purpose allowing the proximal opening to be sealed from fluid (paragraph 11) and to allow for fluid to be administered proximally to the guidewire outlet (fig. 1)
6
Ackermann teaches the claimed features (see discussion above with respect to claims 14 and 16). It would have been obvious to have modified the issued claim for the same reasons given above for claims 14 and 16.
7
Ackermann teaches the inflation inlet and the inflation outlet are different from the infusion inlet and the infusion outlet (see annotated figure above and infusion outlet 310a and the outlet of lumen 130 in fig. 1). Therefore, it would have been obvious to have modified the issued patent with the claimed features to allow for the introduction of separate infusion and inflation fluids.
8
Ackermann teaches the proximal guidewire opening and the distal guidewire opening are different from the infusion inlet and the infusion outlet (see annotated figure above and fig. 1). Therefore, it would have been obvious to have modified the issued claim for the purpose allowing the proximal opening to be sealed from fluid (paragraph 11) and to allow for fluid to be administered proximally to the guidewire outlet (fig. 1)
9
Ackermann teaches the inflation inlet and the inflation outlet are different from the proximal guidewire opening and the distal guidewire opening (see annotated figure above and fig. 1). Therefore, it would have been obvious to have modified the issued claim to have the claimed features for the purpose of allowing the proximal opening to be sealed from fluid (paragraph 11) and to allow a guidewire to extend completely through the catheter (fig. 1).
10
3
11
3
12
6
13
5
14
9
15
Ackermann teaches the infusion outlet is located adjacent to the inflatable member (310a in fig. 1). Therefore, it would have been obvious to have modified the issued claim since Ackermann teaches the infusion outlet can be placed anywhere along the shaft (paragraph 45).
16
1
See discussion above
17
2
Claim 2 of the issued patent does not claim the inflation inlet is located in the proximal connector and the inflation outlet opens to an inner volume of the inflatable member. Ackermann teaches the inflation inlet is located in the proximal connector (see annotated figure above) and the inflation outlet opens to an inner volume of the inflatable member (fig. 1 shows the outlet of lumen 130 opening to balloon 410). Therefore, it would have been obvious to have modified the issued claim to have the claimed features for allowing inflation fluid to travel from an inflation source to the inflatable member for inflation.
18
Ackermann teaches the inflation inlet and the inflation outlet are different from the infusion inlet and the infusion outlet (see annotated figure above and infusion outlet 310a and the outlet of lumen 130 in fig. 1). Therefore, it would have been obvious to have modified the issued patent with the claimed features to allow for the introduction of separate infusion and inflation fluids.
19
Ackermann teaches the infusion outlet is located adjacent to the inflatable member (310a in fig. 1). Therefore, it would have been obvious to have modified the issued claim since Ackermann teaches the infusion outlet can be placed anywhere along the shaft (paragraph 45).
20
6
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12064588 in view of Ackermann (see table below).
Regarding claims 1 and 16, claim 1 of the issued patent claims all of the claimed limitations set forth in instant claims 1 and 16 except that proximal connector is a triple connector connected to the proximal section of the shaft.
As discussed previously, Ackermann teaches a triple connector connected to a proximal section of the shaft (manifold 600’ in fig. 6). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the proximal connector of the issued patent to be the claimed triple connector, as taught by Ackermann. Ackermann teaches that this modification allows for easy connection to sources of inflation fluid and medicament while also allow delivery of a guidewire (paragraph 53).
Instant Claims
Patent Claims
Teaching
1
1
see discussion above
2
2
3
3
4
4
5
5
6
6
7
7
8
8
9
9
10
10
11
11
12
12
13
13
14
14
15
15
16
1
17
2
18
3
19
15
20
12
Allowable Subject Matter
Claims 1-20 would be allowable with the filing of a terminal disclaimer to overcome the double patenting rejection above.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the closest prior art is Ackermann which does not teach or disclose an inflatable member provided distally to the intermediate section and over the distal section. The claim recites that the first lumen is narrowed to approximate a first diameter along an entire length of the distal section. The examiner notes that this limitation is interpreted to mean that the first lumen comprises this first diameter along the entire length of the distal section. This interpretation appears aligned with Applicant’s invention, as seen in fig. 7A which shows the distal section 113 as comprising a narrowed diameter extending along the entire length of the distal section. As seen in Ackermann (fig. 9), the distal section is considered to be the small portion of the shaft which comprises a narrowed first diameter (see annotated figure above). The inflatable member of Ackermann is positioned proximally to this section (fig. 1) and, therefore, does not extend over the distal section, as required by the claim.
Regarding claims 1 and 16, the closest prior art is Ackermann which does not teach or disclose a first lumen narrowed to approximate a first diameter in the proximal section of the shaft, in combination with the total structure and function as claimed. Ackermann teaches a shaft (inner tubular member 300 in fig. 4) which is connected to a triple connector (manifold 600 in fig. 4) at its proximal end (fig. 4). Ackermann discloses a guidewire seal which would narrow the first lumen to the claimed first diameter (sealing member 640’ in fig. 6; paragraph 53). However, this narrowing is shown to be in the guidewire port (port 630’ in fig. 6) of the triple connector and not the proximal section of the shaft, as required by the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Patton (US 7873404) discloses a similar infusion catheter (fig. 1) which comprises a distal section (portion 26 in fig. 1) which continuously tapers to a diameter which approximates the diameter of the guidewire at the distal tip of the catheter shaft (3:64-67) so that the first lumen is not narrowed to the first diameter along an entire length of the distal section. Additionally, Patton discloses an inflatable member (balloon 24 in fig. 1) which is positioned proximally to this section.
Zattera (US 20060253071) discloses a similar infusion catheter (fig. 1) comprising a triple proximal connector (fig. 1) and a first lumen (cavity 20 in fig. 1) which comprises a distal section which is narrowed to a first diameter along an entire length of the distal section (taper 46 in fig. 5). Zattera teaches that the inflatable member (occluding means 60 in fig. 5) is positioned proximally to the distal section (fig. 5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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