DETAILED ACTION
CLAIM INTERPRETATION
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘elongated tube’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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, 2, 9, 3, 4, 5, 6, 7, 8, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 5, 9, 10, 11 of U.S. Patent No. 12,295,581. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims 1, 2, and 9 are anticipated by the reference patent claim 1. Reference patent 1 of U.S. Patent No. 12,295,581 recites that the wire has a tip and is inserted into the lumen, the tip terminates at the distal neck, at least one connection piece is coupled to a proximal end of the inflatable balloon portion and defines at least one port for insertion of the wire and injection of fluid and the instant claim does not. A person of ordinary skill in the art would have viewed the omission as an obvious variant because at least one connection piece and wire tip is not required to inflate the balloon to occlude a blood vessel.
Claims from Instant Application (19/177897)
Corresponding Claims from U.S. Patent No. 12,295,581
Claims 1, 2, 9
Claim 1
Claim 3
Claim 2
Claim 4
Claim 5
Claim 5
Claim 4
Claim 6
Claim 5
Claim 7
Claim 9
Claim 8
Claim 10
Claim 10
Claim 11
Claims 11, 18, 12, 13, 14, 15, 16, 17, 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 5, 9, 10, 11 of U.S. Patent No. 11,801,057. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims 11 and 18 are anticipated by the reference patent claim 1. Reference patent 1 of U.S. Patent No. 11,801,057 recites at least one connection piece is coupled to a proximal end of the inflatable balloon portion and defining at least one port for insertion of the wire and injection of fluid and the instant claim does not. A person of ordinary skill in the art would have viewed the omission as an obvious variant because at least one connection piece and wire tip is not required to inflate the balloon to facilitate occluding a blood vessel.
Claims from Instant Application (19/177897)
Corresponding Claims from U.S. Patent No. 11,801,057
Claims 11 and 18
Claim 1
Claim 12
Claim 2
Claim 13
Claim 3
Claim 14
Claim 4
Claim 15
Claim 5
Claim 16
Claim 9
Claim 17
Claim 10
Claim 19
Claim 11
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "the device" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 12, 13, and 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Radl et al. (US 2019/0105057A1, “Radl”).
Regarding claim 11, Radl discloses an occlusion assembly capable of occluding a blood vessel. The assembly includes an elongated shaft (Fig. 8) defining a single lumen therein. The shaft consists of an inflatable balloon portion (236) having distal and proximal ends, a distal neck portion (236C) attached to the distal end of the inflatable balloon portion, and a proximal neck portion (236B) attached to the proximal end of the inflatable balloon portion. The lumen extends through at least the proximal neck portion and the inflatable balloon portion. The inner lumen is constructed and arranged to act as a flow channel for passage of a fluid [0114] and to contain a wire having a tip terminating in the distal neck portion. It is noted that the claim limitation “constructed and arrange……to contain a wire having a tip terminating in the distal neck portion” does not appear to positively recite the wire. The Examiner suggests amending the claim to positively recite the wire to avoid misinterpretation. For example, “the inner lumen contains a wire having a tip terminating in the distal neck portion”. For the purposes of art rejection, the Examiner has interpreted the claim as not positively reciting the wire.
Regarding claim 12, Radl discloses that the inflatable balloon portion, the distal neck portion and the proximal neck portion are a single integral structure (Fig. 8).
Regarding claim 13, Radl discloses that the inflatable balloon portion, the distal neck portion and the proximal neck portion are constructed from polyurethane [0096].
Regarding claim 15, Radl discloses that the inflatable balloon portion has a conical shape (Fig. 8).
Claim(s) 11-15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Franklin et al. (US 2018/0236203A1, “Franklin”).
Regarding claim 11, Franklin discloses an occlusion assembly capable of occluding a blood vessel. The assembly includes an elongated shaft (Fig. 28) defining a single lumen therein. The shaft consists of an inflatable balloon portion having distal and proximal ends (1208, 1212), a distal neck portion (1200c) attached to the distal end of the inflatable balloon portion and a proximal neck portion (1200b) attached to the proximal end of the inflatable balloon portion. The lumen extends through at least the proximal neck portion and the inflatable balloon portion. The inner lumen is constructed and arranged to act as a flow channel for passage of a fluid [0219] and to contain a wire having a tip terminating in the distal neck portion. It is noted that the claim limitation “constructed and arrange……to contain a wire having a tip terminating in the distal neck portion” does not appear to positively recite the wire. The Examiner suggests amending the claim to positively recite the wire to avoid misinterpretation. For example, “the inner lumen contains a wire having a tip terminating in the distal neck portion”. For the purposes of art rejection, the Examiner has interpreted the claim as not positively reciting the wire.
Regarding claim 12, Franklin discloses that the inflatable balloon portion, the distal neck portion and the proximal neck portion are a single integral structure (Fig. 28).
Regarding claim 13, Franklin discloses that the inflatable balloon portion, the distal neck portion and the proximal neck portion are constructed from PET [0217].
Regarding claim 14, Franklin discloses that the inflatable balloon portion, distal and proximal necks are sized for zone 1, zone 2 or zone 3 deployment [0034, 0030-0031].
Regarding claim 15, Franklin discloses that the inflatable balloon portion has a spherical shape (Fig. 28).
Claim(s) 11-13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Becker (US 2004/0064150A1).
Regarding claim 11, Becker discloses an occlusion assembly capable of occluding a blood vessel. The assembly includes an elongated shaft (134;Fig. 1) defining a single lumen therein (tube (136) extends through the lumen). The shaft consists of an inflatable balloon portion (174) having distal and proximal ends, a distal neck portion (172) attached to the distal end of the inflatable balloon portion, and a proximal neck portion (176) attached to the proximal end of the inflatable balloon portion. The lumen extends through at least the proximal neck portion and the inflatable balloon portion. The inner lumen is constructed and arranged to act as a flow channel for passage of a fluid, wherein tube (136) extends therethrough and includes port (140) through which fluid may pass. The lumen is constructed and arranged to contain a wire having a tip terminating in the distal neck portion. It is noted that the claim limitation “constructed and arrange……to contain a wire having a tip terminating in the distal neck portion” does not appear to positively recite the wire. The Examiner suggests amending the claim to positively recite the wire to avoid misinterpretation. For example, “the inner lumen contains a wire having a tip terminating in the distal neck portion”. For the purposes of art rejection, the Examiner has interpreted the claim as not positively reciting the wire.
Regarding claim 12, Becker discloses that the inflatable balloon portion, the distal neck portion and the proximal neck portion are a single integral structure (Fig. 1)
Regarding claim 13, Becker discloses that the inflatable balloon portion, the distal neck portion and the proximal neck portion are constructed from PET [0041].
Regarding claim 15, Becker discloses that the inflatable balloon portion has a tubular shape (Fig. 1).
Claim(s) 11-13 and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boudreault et al. (US 2009/0312807A1, “Boudreault”).
Regarding claims 11 and 13, Boudreault discloses an occlusion assembly capable of occluding a blood vessel. The assembly includes an elongated shaft (2702;Fig. 45A) defining a single lumen therein. The shaft consists of an inflatable balloon portion (see marked up figure below) having distal and proximal ends, a distal neck portion attached to the distal end of the inflatable balloon portion, and a proximal neck portion attached to the proximal end of the inflatable balloon portion. The lumen extends through at least the proximal neck portion and the inflatable balloon portion. The inner lumen is constructed and arranged to act as a flow channel for passage of a fluid and to contain and position a wire (stylet; [0137]) in the lumen while having a tip terminating in the distal neck portion. It is noted that it is not clear if the claim limitation “constructed and arrange……to contain a wire having a tip terminating in the distal neck portion” positively recites the wire. The Examiner suggests amending the claim to positively recite the wire. For example, “the inner lumen contains a wire having a tip terminating in the distal neck portion”. For the purposes of art rejection, the Examiner has interpreted the claim as positively reciting the wire. It is noted that a stylet is defined as a wire run through a catheter or cannula to stiffen it or clear it (Oxford Languages).
PNG
media_image1.png
235
509
media_image1.png
Greyscale
Regarding claim 12, Boudreault that the inflatable balloon portion, the distal neck portion and the proximal neck portion are a single integral structure (Fig. 45A)
Regarding claim 13, Boudreault discloses that the inflatable balloon portion, the distal neck portion and the proximal neck portion are constructed from polyurethane, nylon, or PET [0112].
Regarding claim 15, Boudreault discloses that the inflatable balloon portion has a tubular shape (Fig. 45A).
Regarding claim 16, Boudreault discloses that the distal neck portion terminates at a sealed plug (2706) such that the wire tip terminates adjacent to the sealed plug [0137].
Regarding claim 17, Boudreault discloses that the wire tip is a straight to provide atraumatic passage of the elongated shaft through the blood vessel (Fig. 45A).
Claim(s) 11-13, and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wolvek et al. (US 4,276,874, “Wolvek”).
Regarding claim 11, Wolvek discloses an occlusion assembly capable of occluding a blood vessel. The assembly includes an elongated shaft (28;Fig. 3) defining a single lumen therein. The shaft consists of an inflatable balloon portion (see marked up figure below) having distal and proximal ends, a distal neck portion attached to the distal end of the inflatable balloon portion, and a proximal neck portion attached to the proximal end of the inflatable balloon portion. The lumen extends through at least the proximal neck portion and the inflatable balloon portion. The inner lumen is constructed and arranged to act as a flow channel for passage of a fluid and to contain and position a wire (46) in the lumen while having a tip terminating in the distal neck portion. It is noted that it is not clear if the claim limitation “constructed and arrange……to contain a wire having a tip terminating in the distal neck portion” positively recites the wire. The Examiner suggests amending the claim to positively recite the wire. For example, “the inner lumen contains a wire having a tip terminating in the distal neck portion”. For the purposes of art rejection, the Examiner has interpreted the claim as positively reciting the wire. It is noted that a wire is defined as a thin flexible thread or rod (Oxford Languages).
PNG
media_image2.png
813
388
media_image2.png
Greyscale
Regarding claim 12, Wolvek discloses that the inflatable balloon portion, the distal neck portion and the proximal neck portion are a single integral structure (Fig. 3)
Regarding claim 13, Wolvek discloses that the inflatable balloon portion, the distal neck portion and the proximal neck portion are constructed from polyurethane (C5;L67-69).
Regarding claim 15, Wolvek discloses that the inflatable balloon portion has a tubular shape (Fig. 3).
Regarding claim 16, Wolvek discloses that the distal neck portion terminates at a sealed plug (32) such that the wire tip terminates adjacent to the sealed plug (Fig. 3).
Regarding claim 17, Wolvek discloses that the wire tip is a straight to provide atraumatic passage of the elongated shaft through the blood vessel (Fig. 3).
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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radl in view of Franklin.
Regarding claim 14, Radl does not disclose that the inflatable balloon portion, distal and proximal neck portions are sized for zone 1, zone 2 or zone 3.
Radl discloses the use and inflation of the balloon in the aorta [0123]. In the same field of endeavor, balloons, Franklin teaches selecting a balloon to occlude flow inside the aorta and zone 1, zone 2 and zone 3 [0030-0031]. 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 sized the balloon of Radl with the required dimensions to provide access to zones 1, 2 or 3, as taught by Franklin, to provide means for efficiently occluding the site.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolvek in view of Franklin.
Regarding claim 14, Wolvek does not disclose that the inflatable balloon portion, distal and proximal neck portions are sized for zone 1, zone 2 or zone 3.
Wolvek discloses the use and inflation of the balloon in the aorta (C5,L50-55). In the same field of endeavor, balloons, Franklin teaches selecting a balloon to occlude flow inside the aorta and zone 1, zone 2 and zone 3 [0030-0031]. 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 sized the balloon of Wolvek with the required dimensions to provide access to zones 1, 2 or 3, as taught by Franklin, to provide means for efficiently occluding the site.
Claim(s) 1 and 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US 2018/0236203A1, “Franklin”) in view of Forman et al. (US 2010/0036411A1, “Forman”).
Regarding claim 1, Franklin discloses a method of occluding a blood vessel including an elongated tube (Fig. 28) including an inflatable balloon portion having distal and proximal ends (1208, 1212) and inserting a wire into a lumen of the inflatable balloon portion [0032]. A distal neck (1200c) is attached to the distal end of the inflatable balloon portion and a proximal neck (1200b) attached to the proximal end of the inflatable balloon portion. The lumen extends through at least the proximal neck portion and the inflatable balloon portion. The lumen defines a flow channel for a fluid to inflate the inflatable balloon portion when fluid is injected into the lumen from a proximal end of the elongated tube [0219]. Franklin discloses that the balloon may be used for angioplasty, stent placement, or occlusion [0017], wherein the balloon is introduced through percutaneous sheath and maneuvered into a patient’s blood vessels until the balloon is positioned in the target location. Femoral artery access is made via the percutaneous sheath [0017]. The sheath is placed into the artery [0017]. Once properly in position, the balloon is inflated with liquid to a predetermined size and pressure to widen the passageway [0023]. However, Franklin does not disclose that the wire and elongated tube is inserted into the artery through the sheath or angiocatheter.
In the same field of endeavor, vascular interventional procedures, Forman teaches the method of making an incision in a femoral artery by puncturing with a hollow vascular needle, withdrawing the needle, placing a guide catheter into the incision, inserting a guide wire into the lumen of the guide catheter, and advancing the balloon over the guide wire until it reaches the target location [0094]. 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 provided the method of Franklin with inserting a guide wire into the lumen of the guide catheter and advancing the balloon over the guide wire until it reaches the target location, as taught by Forman, to provide means for guiding the balloon to the target location.
Regarding claim 3, the combination of Franklin and Forman discloses that the distal and proximal neck are a single integral structure (Fig. 28).
Regarding claim 4, the combination of Franklin and Forman discloses that the inflatable balloon portion, distal and proximal necks are formed of PET [0217].
Regarding claim 5, the combination of Franklin and Forman discloses that the inflatable balloon portion, distal and proximal necks are sized for zone 1, zone 2 or zone 3 deployment [0034, 0030-0031].
Regarding claim 6, the combination of Franklin and Forman discloses that the inflatable balloon portion has a round shape (Fig. 28).
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolvek et al. (US 4276874, “Wolvek”) in view of Franklin.
Regarding claim 1, Wolvek discloses a method of occluding a blood vessel including an elongated tube including an inflatable balloon portion (Fig. 11) having a dual or multi-chamber balloon portion. The balloon portion includes distal and proximal ends. A distal neck (near tip 32) is attached to the distal end of the inflatable balloon portion and a proximal neck (117) attached to the proximal end of the inflatable balloon portion. A lumen (44) extends through at least the proximal neck portion and the inflatable balloon portion. The lumen defines a flow channel for a fluid to inflate the inflatable balloon portion when fluid is injected into the lumen from a proximal end of the elongated tube (C6;L19-33). A wire (46) is inserted into the lumen. The balloon is introduced through a femoral artery, fluid is injected into the lumen from the proximal end of the elongated tube to inflate the inflatable balloon portion and occlude the artery (Fig. 12). However, Wolvek does not disclose puncturing an artery by inserting a sheath or a syringe and angiocatheter, inserting the elongated tube and wire into the artery through the sheath to an appropriate length to reach a target location.
In the same field of endeavor, treating obstructions within body lumens, Franklin teaches the method of puncturing a femoral artery via a percutaneous sheath [0017], placing the sheath through the puncture, and advancing the balloon through the sheath until it reaches the target location. 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 provided the method of Wolvek with puncturing a femoral artery with a sheath, inserting a sheath into the incision, and advancing the balloon until it reaches the target location, as taught by Franklin, to provide means for guiding the balloon to the target location.
Regarding claim 2, the combination of Wolvek and Franklin discloses that the lumen terminates at the distal neck, the wire has a tip such that when the wire is inserted into the lumen the tip terminates at the at the distal neck portion (Fig. 11; Wolvek).
Regarding claim 3, the combination of Wolvek and Franklin discloses that the distal and proximal neck are a single integral structure (Fig. 11; Wolvek).
Regarding claim 4, the combination of Wolvek and Franklin discloses that the inflatable balloon portion, distal and proximal necks are formed of polyurethane (C5;L67-69; Wolvek).
Regarding claim 5, the combination of Wolvek and Franklin discloses that the artery is a femoral artery and that the inflatable portion, distal and proximal necks are sized for zone 1, 2 or 3 deployment [0034, 0030-0031, 0035; Franklin]. Regarding claim 6, the combination of Wolvek and Franklin discloses that the inflatable balloon portion has a tubular shape (Fig. 11; Wolvek).
Regarding claim 7, as best understood, the combination of Wolvek and Franklin discloses that the distal neck portion terminates at a sealed plug (32) such that the wire tip terminates adjacent to the sealed plug (Fig. 11; Wolvek).
Regarding claim 8, the combination of Wolvek and Franklin discloses that the wire tip is straight to provide atraumatic passage of the elongated shaft through the blood vessel (Fig. 11; Wolvek).
Regarding claims 9 and 10, the combination of Wolvek and Franklin discloses that the elongated tube includes at least one connection piece (luer lock 26; Wolvek) coupled to a proximal end of the inflatable balloon portion and in fluid communication with the lumen. The at least one connection piece defines at least one port for insertion of the wire and for injection of the fluid.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Menasche (US 4,927,412) discloses an elongated shaft defining a single lumen therein. The shaft consists of an inflatable balloon portion having distal and proximal ends, a distal neck portion attached to the distal end of the inflatable balloon portion, and a proximal neck portion attached to the proximal end of the inflatable balloon portion. The lumen extends through at least the proximal neck portion and the inflatable balloon portion. However, Menasche does not disclose at least one connection piece coupled to a proximal end of the elongated shaft, wherein the connection piece may be a luer lock or a valve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
Prosecution Insights