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 .
Response to Amendment
Claims 1-5, 7, 10-14, and 16-24 are pending in the application. Claims 6, 8, 9, 15, and 25 have been canceled. Claims 23 and 24 have been withdrawn from consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/29/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-5, 7, 10-14, and 16-22) in the reply filed on 6/10/26 is acknowledged. The traversal is on the ground(s) that claims 1, 16, and 23-24 each now require the combination of a perfusion balloon including an internal passage and another balloon for positioning in a branch vessel. The Applicant has argued that this feature is not disclosed, taught, or suggested in the El-Nounou et al. reference. This is not found persuasive because the El-Nounou et al. reference does disclose this feature. In paragraph 0037, the El-Nounou et al. reference discloses that the inflatable balloon (20) has an internal passage that allows fluid flow in the main vessel (50) when inflated. The El-Nounou et al. reference also discloses another balloon (21) for positioning in a branch vessel (51). The features are not special technical features as they do not make a contribution over the El-Nounou et al. reference.
The requirement is still deemed proper and is therefore made FINAL.
Claims 23 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/10/26.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 4, “the balloon” should read --the first inflatable balloon--. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: in line 2, “the balloon” should read --the first inflatable balloon--. 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.
Claims 1-4, 7, 12, 13, 16, 17, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 2007/0150044 A1) (“Wang”).
Regarding claim 1, Wang discloses (Figures 1-4C, 9-9B) an apparatus capable of performing a medical procedure in a main vessel (AO) connected to a branch vessel (RA), comprising: a first inflatable balloon (98) forming an internal passage (92) for allowing perfusion in the main vessel when the inflatable balloon is inflated (paragraph 0047), the balloon having an external surface; a shaft (18) including an inflation lumen (35) in communication with the inflatable balloon (paragraph 0036), and a working lumen (20) including an outlet along the external surface for passing a tool (GW); and a second inflatable balloon (12) connected to the shaft for insertion into the branch vessel when inflated (paragraphs 0047-0048).
Regarding claim 2, Wang discloses (Figures 6A-6C, 9) that the shaft (18) comprises an elbow (65) extending along a portion (95) of the external surface of the first inflatable balloon (paragraph 0026).
Regarding claim 3, Wang discloses (Figure 9) that the shaft (18) comprises a first port (28) for communicating inflation fluid to an interior compartment of the first inflatable balloon (paragraph 0036).
Regarding claim 4, Wang discloses (Figure 9) that a portion (95) of the external surface of the first inflatable balloon (98) is located in a recess for receiving a portion of the shaft (paragraph 0047).
Regarding claim 7, Wang discloses (Figure 9) that the second inflatable balloon (12) comprises an indexing balloon connected to the shaft, the shaft further including a second port (27) in fluid communication with an interior compartment of the indexing balloon (paragraph 0036), wherein the indexing balloon is adapted for being at least partially inserted into the branch vessel (Figure 9).
Regarding claim 12, Wang discloses (Figures 1-4C, 9-9B) an apparatus for performing a medical procedure in a main vessel (AO) connected to a branch vessel (RA), comprising: a first inflatable balloon (98) forming an internal passage (92) for allowing perfusion in the main vessel when the first inflatable balloon is inflated (paragraph 0047); a shaft (18) connected to the first inflatable balloon, the shaft including an inflation lumen (35) in communication with the first inflatable balloon; and a second inflatable balloon (12) connected to the shaft for insertion into the branch vessel when inflated (paragraphs 0047-0048).
Regarding claim 13, Wang discloses that the second inflatable balloon is positioned proximally of the first inflatable balloon along the shaft (the first balloon extends distally beyond the second inflatable balloon), and oriented in substantially a common direction as an outlet of a working lumen (20) of the shaft (GW extending out of outlet in Figure 9).
Regarding claim 16, Wang discloses (Figures 6A-6C, 9) that the shaft (18) comprises an elbow (65; paragraph 0026)
Regarding claim 17, Wang discloses the shaft (18) comprises a port (28) for communicating inflation fluid to an interior compartment of the first inflatable balloon (paragraph 0036).
Regarding claim 22, Wang discloses that the first inflatable balloon (98) is compliant or semi-compliant (silicone/polyurethane, paragraph 0035) and the second inflatable balloon (12) is non-compliant (nylon/polyester, paragraph 0035).
Claims 1, 5, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ren et al. (US 2007/0225750 A1) (“Ren”).
Regarding claim 1, Ren discloses (Figures 4A-5C) an apparatus capable of performing a medical procedure in a main vessel (V) connected to a branch vessel (B1/B2), comprising: a first inflatable balloon (52) forming an internal passage (64) for allowing perfusion in the main vessel when the inflatable balloon is inflated (paragraph 0055), the balloon having an external surface; a shaft (54) including an inflation lumen (58) in communication with the inflatable balloon (paragraph 0058), and a working lumen (56) including an outlet (60) along the external surface for passing a tool (paragraph 0054); and a second inflatable balloon (52) connected to the shaft capable of being inserted into the branch vessel when inflated.
Regarding claim 5, Ren discloses (Figure 4A) the outlet (60) of the working lumen is substantially flush with a portion of the external surface of the first inflatable balloon (52).
Regarding claim 12, Ren discloses (Figures 4A-5C) an apparatus capable of performing a medical procedure in a main vessel (V) connected to a branch vessel (B1/B2), comprising: a first inflatable balloon (52) forming an internal passage (64) for allowing perfusion in the main vessel when the first inflatable balloon is inflated (paragraph 0055); a shaft (54) connected to the first inflatable balloon, the shaft including an inflation lumen (58) in communication with the first inflatable balloon (paragraph 0058); and a second inflatable balloon (52) connected to the shaft capable of being inserted into the branch vessel when inflated.
Regarding claim 14, Ren discloses (Figure 4A) the second inflatable balloon (52) is in fluid communication with the inflation lumen (58) of the shaft, and the shaft further includes a working lumen (56) including an outlet (60) capable of receiving a retractable needle for puncturing the main or branch vessels (paragraph 0054). NOTE: the needle is not positively recited. Ren discloses that the working lumen is dimensioned to slideably receive interventional devices such as guidewires, balloon catheters, stent delivery systems with stents mounted thereon, atherectomy catheters, embolic protection devices such as distal embolic protection devices, thrombectomy devices, ultrasound catheters, aspiration catheters, and other devices (all not shown) known in that art and can have an internal diameter ranging from 0.012 inch to 0.200 inch (0.030 cm to 0.51 cm), more preferably from 0.040 inch to 0.110 inch (0.10 cm to 0.28 cm), more preferably from 0.060 inch to 0.096 inch (0.15 to 0.24 cm). The working lumen disclosed by Ren is capable of receiving a guidewire as claimed.
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.
Claims 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2007/0150044 A1) (“Wang”) in view of Avellanet (US 5,613,948).
Regarding claims 11 and 18, Wang discloses the invention substantially as claimed. However, Wang fails to disclose the shaft is connected between two layers of the first inflatable balloon.
Avellanet teaches (Figures 1-3) a perfusion balloon catheter with a shaft (104) connected between two layers (116, 118) of an inflatable balloon (102).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft disclosed by Wang to be connected between two layers of the first inflatable balloon, as taught by Avellanet. Avellanet teaches that this is a suitable means to connect a perfusion balloon to a catheter shaft to provide a cylindrically shaped balloon that may remain in its expanded condition for a considerably longer time than conventional catheters because the blood is perfused past the balloon through longitudinal passageway without need for a separate mechanism to pump or channel the blood (Avellanet, Column 4, lines 1-5).
Claims 10 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2007/0150044 A1) (“Wang”) in view of Van Moorlegem et al. (US 2002/0049408 A1) (“Van Moorlegem”).
Regarding claims 10 and 18, Wang discloses the invention substantially as claimed. However, Wang fails to disclose that the shaft is connected to the external surface of the first inflatable balloon.
Van Moorlegem teaches (Figure 4a) a perfusion balloon catheter with a shaft (102) that is connected to the external surface of the balloon.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft disclosed by Wang to be connected to the external surface of the balloon, as taught by Van Moorlegem. This modification would improve the overall flexibility by lowering the overall moment of inertia of the assembly (paragraph 0033). This configuration results in a perfusion balloon, by virtue of its large aperture that enables continued blood flow, can stay in a patient's body for protracted periods of time, and that after such extended period, the balloon can be deflated and removed. This can be of great benefit in lengthy surgical procedures (Van Moorlegem, paragraph 0036).
Regarding claim 19, Wang as modified by Van Moorlegem teaches (Wang, Figure 9) that a portion (95) of the external surface of the first inflatable balloon (98) is located in a recess for receiving a portion of the shaft (Wang, paragraph 0047).
Regarding claim 20, Wang as modified by Van Moorlegem teaches (Wang, Figures 1, 3, 4, 6A-6C, 8A) that the shaft includes a working lumen (20) having an outlet (24) substantially flush with the external surface of the first balloon.
Regarding claim 21, Wang as modified by Van Moorlegem teaches (Wang, Figures 1, 3, 4, 6A-6C, 8A) that the second inflatable balloon (12) includes a projection (14) oriented in a common direction as the outlet (24) of the working lumen. The stent (14) forms a protrusion on an outer surface of the second inflatable balloon (12) that is oriented in a radially outward direction, common to the outlets (24).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Pursley (US 2013/0303897 A1; Figures 6-16 and 28-31) devices for performing a medical procedure in a main vessel connected to a branch vessel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.D.K/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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