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
The amendment filed 05/13/2026 has been entered. Claims 1-21 are pending in the application, claims 22-40 are canceled.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-21 in the reply filed on 05/13/2026 is acknowledged. Claims 22-40 are withdrawn and canceled from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “sharp edge” recited in claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20: On line 2, “balloon member if formed” is grammatically incorrect and should recite “balloon member is formed”.
Appropriate correction is required.
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 1-21 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 1 recites the limitation “a proximal portion, a distal portion, and a middle portion positioned between said proximal and middle portions” in lines 4-5. It is unclear how the middle portion can be positioned between itself and the proximal portion. For the sake of examination, the limitation will be interpreted as reciting “a proximal portion, a distal portion, and a middle portion positioned between said proximal and distal portions”.
Claim 2 recites the limitation “The intravascular guide catheter extension system of claim 1, configured for delivery in the blood vessel of interest from one end thereof, further comprising an additional catheter configured for delivery into the blood vessel of interest from another end thereof”. As written, it appears that the intravascular guide catheter extension system of claim 1 is one thing and the additional catheter is another thing outside of the claimed invention. Thus, it is unclear is the additional catheter is a part of the claimed system or not. For the sake of examination, the limitation will be interpreted as reciting “The intravascular guide catheter extension system of claim 1, wherein the outer member and inner member are configured for delivery in the blood vessel of interest from one end thereof, further comprising an additional catheter configured for delivery into the blood vessel of interest from another end thereof”.
Claim 3 recites the limitation “The intravascular guide catheter extension system of claim 2, being an antegrade guide catheter extension system, wherein said additional catheter is a retrograde catheter”. Similar to claim 2, it is unclear if the additional/retrograde catheter is a part of the claimed system or not. For the sake of examination, the limitation will be in interpreted as reciting “The intravascular guide catheter extension system of claim 2, the outer member and inner member being an antegrade guide catheter extension system, wherein said additional catheter is a retrograde catheter”.
Claim 9 recites “during retraction of said outer member from the guide catheter, said plurality of wing members are plastically compressed”. It is unclear the meets and bounds of the claim since this limitation appears to be a method step while the claims are directed to an apparatus. For the sake of examination, the limitation will be interpreted as reciting “the radially expandable scaffold member is configured such that during retraction of said outer member from the guide catheter, said plurality of wing members are plastically compressed”.
Claim 9 recites the limitation "the guide catheter" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the sake of examination, the limitation will be interpreted as reciting “a guide catheter”.
Claim 10 recites “in said deflated configuration, said balloon member is displaced in the blood vessel of interest, and wherein said balloon member is controllably transformed into said inflated configuration subsequent to being positioned at least in alignment with a site of interest for expanding said distal opening of said radially expandable scaffold member”. It is unclear the meets and bounds of the claim since this limitation appears to be a method step while the claims are directed to an apparatus. For the sake of examination, the limitation will be interpreted as reciting “in said deflated configuration, said balloon member is displaceable in the blood vessel of interest, and wherein said balloon member is configured to controllably transformed into said inflated configuration subsequent to being positioned at least in alignment with a site of interest for expanding said distal opening of said radially expandable scaffold member”
Claims 4-8, 11-21 are rejected as depending from a rejected claim.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-6, 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Farhangnia (US 2014/0207179) in view of Gianotti (US 2013/0237950).
Regarding Claim 1, Farhangnia discloses an intravascular guide catheter extension system for reverse controlled antegrade and retrograde tracking (CART) procedure for chronic total occlusion (CTO) in a blood vessel of interest, the intravascular guide catheter extension system comprising: a proximal portion, a distal portion, and a middle portion positioned between said proximal and distal portions, an outer member (469, Fig 12D) comprising an outer sheath defining an outer sheath lumen configured with an outer tip at a distal end and a radially expandable scaffold member (471, Fig 12D; Examiner notes that the scaffold is misnumbered as 473 in Fig 12D but is referred to and described throughout the specification as element 471, Para 0142) at said outer tip, wherein said radially expandable scaffold member comprises an elongated member shaped into a zig-zag configuration to form a plurality of wing members extending longitudinally along said outer sheath and disposed circumferentially around a longitudinal axis of said outer sheath (Para 0142; Also see scaffold 471 in Fig 9C), said plurality of wing members defining a distal opening and a proximal opening of said radially expandable scaffold member, wherein in a closed configuration said wing members of said radially expandable scaffold member are arranged in a cylindrical formation (Para 0162, sheath 467 holds scaffold in an unexpanded position defined by the shape of the sheath, i.e. cylindrical), and wherein in an opened configuration said scaffold member is deformed to displace said wing members to expand said distal opening (Para 0162); an inner member (473, Fig 12D) having an elongated body defining an internal channel extending along a longitudinal axis thereof, said inner member extending internally along said outer sheath lumen of said outer sheath (Para 0162), wherein said inner member has a tapered distal tip configured with a tapered delivery micro-catheter having an elongated body of a predetermined length (Para 0063);
Farhangnia is silent regarding a balloon member attached to said tapered distal tip of said inner member, wherein a proximal section of said balloon member is positioned internally of said radially expandable scaffold member at said distal end of said outer sheath; and an inflation lumen extending inside said inner member between a proximal portion of said intravascular guide catheter extension system and said balloon member to provide a fluid passage between a balloon inflation system and said balloon member, wherein said balloon member is configured to assume an inflated configuration by actuating the balloon inflation system to expand and causes said radially expandable scaffold member to assume said opened configuration thereof.
Gianotti teaches an inner member (110, Fig 4) and an outer member (120, Fig 4); a balloon member (140, Fig 4) attached to said tapered distal tip (61, Fig 12B) of said inner member, wherein a proximal section of said balloon member is positioned internally of said distal end of said outer sheath and configured to dilate a blockage within the blood vessel of interest (Para 0006) and attached to said tapered distal tip of said inner member (Para 0120); ; and an inflation lumen (130, Fig 3) extending inside said inner member between a proximal portion of said intravascular guide catheter extension system and said balloon member to provide a fluid passage between a balloon inflation system and said balloon member, wherein said balloon member is configured to assume an inflated configuration by actuating the balloon inflation system to expand (Para 0065).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner member disclosed by Wilson to include a balloon proximal to the tapered distal tip and an inflation lumen as taught by Gianotti in order to have a device that dilates an obstruction within a body lumen and remodel a vessel wall while maintaining pushability (Para 0006). Examiner notes that the modified invention of Farhangnia and Gianotti would have the inflation of the balloon member cause said radially expandable scaffold member to assume said opened configuration as the balloon would cause the scaffold to further expand where a proximal section of said balloon member is positioned internally of said distal end of said outer sheath.
Regarding Claim 4, the modified invention of Farhangnia and Gianotti discloses said elongated member is fabricated from a material selected from a group consisting of a plastically deformable material, Nitinol (Para 0054 - Farhangnia), stainless steel, cobalt chromium, plastically deformable alloy, plastic, and a combination thereof.
Regarding Claim 5, the modified invention of Farhangnia and Gianotti discloses an elastic distal sheath (460, Fig 9C - Farhangnia) disposed at said distal end of said outer sheath, said elastic distal sheath being formed with a tubularly shaped portion and tapered portion disposed in an encircling relationship with said outer tip of said distal end of said outer sheath and said proximal section of said balloon member, wherein said wing members configured with said elongated member are embedded into said tubularly shaped portion of said elastic distal sheath (Para 0162 - Farhangnia).
Regarding Claim 6, the modified invention of Farhangnia and Gianotti discloses each of said wing members has a distal end and a proximal end, wherein distal ends of said plurality of wing members form said distal opening of said radially expandable scaffold member, wherein proximal ends of said plurality of wing members form said proximal opening of said radially expandable scaffold member, and wherein, in said opened configuration of said radially expandable scaffold member, said distal ends of said wing members space apart from one another, thus defining an increased diameter of said expanded distal opening (See annotated Fig 9C -Farhangnia).
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Regarding Claim 9, the modified invention of Farhangnia and Gianotti discloses the outer member is configured such that during retraction of said outer member from a guide catheter (467, Fig 13B -Farhangnia), said plurality of wing members are plastically compressed inside the guide catheter to allow longitudinal motion of the radially expandable scaffold member inside the guide catheter (Para 0163 -Farhangnia).
Regarding Claim 10, the modified invention of Farhangnia and Gianotti discloses in said deflated configuration, said balloon member is displaced in the blood vessel of interest, and wherein said balloon member is controllably transformed into said inflated configuration subsequent to being positioned at least in alignment with a site of interest for expanding said distal opening of said radially expandable scaffold member (Para 0065 -Gianotti).
Regarding Claim 11, the modified invention of Farhangnia and Gianotti discloses said micro-catheter is shaped with an outermost distal end having a sharp edge (the distal end is tapered; Para 0063 -Farhangnia).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Farhangnia (US 2014/0207179) in view of Gianotti (US 2013/0237950) and further in view of Kugler (US 2018/0092650).
Regarding Claim 2, the modified invention of Farhangnia and Gianotti discloses the outer member and inner member are configured for delivery in the blood vessel of interest from one end thereof (See Fig 13A - Farhangnia), however, is silent regarding the intravascular guide catheter extension system further comprising an additional catheter configured for delivery into the blood vessel of interest from another end thereof, said additional catheter having a proximal end and a distal end, wherein the distal end of said additional catheter is received in said radially expandable scaffold member in said opened configuration, through said expanded distal opening defined by said wing members.
Kugler teaches an analogous intravascular guide catheter extension system having an outer member (634, Fig 6J), an inner member (666, Fig 6J) and further comprising an additional catheter (650, Fig 6I) configured for delivery into the blood vessel of interest from another end thereof, said additional catheter having a proximal end and a distal end, wherein the distal end of said additional catheter is received in said outer member (Para 0051).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular guide catheter extension system to include an additional catheter (“retrograde catheter”) as taught by Kugler in order to aid in treating a severe occlusion when an antegrade approach is unsuccessful (Para 0007).
Regarding Claim 3, the modified invention of Farhangnia, Gianotti, and Kugler the outer member and inner member being an antegrade guide catheter extension system, wherein said additional catheter is a retrograde catheter (Para 0045 -Kugler)
Claims 7-8, 12, 14, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Farhangnia (US 2014/0207179) in view of Gianotti (US 2013/0237950) and in further view of Wilson (US 2018/0193042).
Regarding Claim 7, the modified invention of Farhangnia and Gianotti discloses all of the elements of the inventing as discussed above, however, is silent regarding an interconnection mechanism disposed in an operative coupling with said inner and outer members and controllably actuated to operate said guide catheter extension system intermittently in an engaged or disengaged modes of operation, wherein said interconnection mechanism is configured to prevent a displacement of said inner member relative to said outer member.
Wilson teaches an interconnection mechanism (“detent” and “correspondingly-shaped surface features”) disposed in an operative coupling with said inner and outer members and controllably actuated to operate said guide catheter extension system intermittently in an engaged or disengaged modes of operation, wherein said interconnection mechanism is configured to prevent a displacement of said inner member relative to said outer member (Para 0161).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular guide catheter extension system to include an interconnection mechanism as taught by Wilson in order to improve the outer and inner member tracking through a tortuous and often diseased vasculature (Para 0161).
Regarding Claim 8, the modified invention of Farhangnia, Gianotti, and Wilson discloses in said engaged mode of operation, said inner and outer members of said guide catheter extension sub-system are engaged for a controllable common displacement along a guide wire, wherein, in said disengaged mode of operation, said inner and outer members are disengaged for retraction of said inner member from said outer member subsequent to deflation of said balloon member (Para 0161 -Wilson), and wherein, during and upon the retraction of said inner member from said outer member, said radially expandable scaffold member retain the opened configuration thereof (Para 0162 – Farhangnia; the scaffold is self-expanding, thus does not rely on the inner member).
Regarding Claim 12, the modified invention of Farhangnia and Gianotti discloses all of the elements of the inventing as discussed above, however, is silent regarding an outer member pusher configured with a flattened portion at a distal end thereof and secured to a proximal end of said outer sheath of said outer member.
Wilson teaches an analogous outer member (200, Fig 2A) having an outer member pusher (230, Fig 4F -Wilson) configured with a flattened portion at a distal end thereof and secured to a proximal end of said outer sheath of said outer member (Para 0128).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer member to have an outer member pusher secured to a proximal end as taught by Wilson in order to greatly speed up the time required to retract and re-advance outer member through the working lumen out the guide catheter (Para 0113).
Regarding Claim 14, the modified invention of Farhangnia, Gianotti, and Wilson discloses said interconnection mechanism (“detent” and “correspondingly-shaped surface features” -Wilson) is selected from a group consisting of a friction-based unit interfacing an outer surface of said inner member and an inner surface of said outer sheath of said outer member, a snap-fit mechanism being configured with at least one snap-fit post formed at said inner member and extending above an external surface thereof, and a combination thereof (Para 0161 -Wilson).
Regarding Claim 16, the modified invention of Farhangnia and Gianotti discloses all of the elements of the inventing as discussed above, however, is silent regarding radio-opaque markers attached to at least a location selected from a group consisting of said distal end of said outer sheath, a distal end of said micro-catheter, said tapered distal tip of said inner member in proximity to said proximal and distal sections of said balloon member, and a combination thereof.
Wilson teaches an analogous micro-catheter (300, Fig 2A) comprising radio-opaque markers (344a-b, Fig 2A) attached to a distal end of said micro-catheter (Para 0158).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microcatheter to have comprising radio-opaque markers in order to provide the user with information regarding the location of the microcatheter within the vasculature (Para 0158).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Farhangnia (US 2014/0207179) in view of Gianotti (US 2013/0237950) and in further view of Wilson‘054 (US 2012/0303054).
Regarding Claim 13, the modified invention of Farhangnia and Gianotti discloses the inflation lumen (130, Fig 3 -Gianotti), however is silent regarding the inflation lumen includes: an inflation lumen hypo-tube coupled, by a proximal end thereof, to the balloon inflation system and configured with a skived portion at a distal end thereof, and an inflation lumen distal shaft having a proximal end overlapping with said skived portion at the distal end of said inflation lumen hypo tube, and a distal end extending towards said balloon member and coupled thereto in fluidly sealed communication therewith
Wilson ‘054 teaches an analogous balloon catheter (100, Fig 1) comprising an inflation lumen (201, Fig 2), wherein the inflation lumen includes: an inflation lumen hypo-tube (200, Fig 2) coupled, by a proximal end thereof, to the balloon inflation system and configured with a skived portion (460, Fig 2) at a distal end thereof, and an inflation lumen distal shaft having a proximal end overlapping with said skived portion at the distal end of said inflation lumen hypo tube, and a distal end extending towards said balloon member and coupled thereto in fluidly sealed communication therewith (Para 0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inflation lumen to have an inflation lumen hypo tube having a skived portion as taught by Wilson ‘054 in order to reinforce the inflation lumen while facilitating a smooth transition in flexibility (Para 0050).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Farhangnia (US 2014/0207179) in view of Gianotti (US 2013/0237950) and in further view of Sutton (US 5,704,926).
Regarding Claim 15, the modified invention of Farhangnia and Gianotti discloses all of the elements of the inventing as discussed above, however, is silent regarding a flat wire helical coil member forming at least a portion of respective walls of a member selected from a group consisting of said outer sheath of said outer member and said micro-catheter, wherein said flat wire helical coil is formed with a material selected from a group comprising Nitinol, a radio-opaque material, and a combination thereof.
Sutton teaches an analogous catheter (10, Fig 2) comprising a flat wire helical coil member (14, Fig 2) forming at least a portion of respective walls of the member, wherein said flat wire helical coil is formed with a material selected from a group comprising Nitinol, a radio-opaque material, and a combination thereof (Col 5, lines 21-35; the wire can be made of tungsten which is radiopaque).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer sheath of said outer member to include a flat wire helical coil member as taught by Sutton in order to have a catheter that can better resist kinking and collapse as well as the ability to better withstand hoop stresses, while still maintaining flexibility (Col 3, lines 28-34).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Farhangnia (US 2014/0207179) in view of Gianotti (US 2013/0237950) and further in view of Bagaoisan (US 2014/0018732).
Regarding Claim 17, the modified invention of Farhangnia and Gianotti discloses all of the elements of the inventing as discussed above, however, is silent regarding a pre-shaped curved portion at the distal portion of said intravascular guide catheter extension system.
Bagaoisan teaches a guide catheter (102, Fig 1A) and an outer member (101, Fig 1A), wherein the outer member has a pre-shaped curved portion (105, Fig 1A) at the distal portion (Para 0116).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer member to have a pre-shaped curved portion as taught by Bagaoisan in order to simplify and ease access to and treatment of a target anatomy, thereby reducing procedure time, equipment burden, and associated costs (Para 0030).
Regarding Claim 18, the modified invention of Farhangnia, Gianotti, and Bagaoisan discloses said curved portion (105, Fig 1A -Bagaoisan) is prefabricated at the distal end of said outer sheath of said outer member (Para 0116 - Bagaoisan).
Regarding Claim 19, the modified invention of Farhangnia, Gianotti, and Bagaoisan discloses at said curved portion said outer sheath angularly deviates from a longitudinal axis of said outer sheath at said proximal end thereof at an angle ranging between 30° and 90° (Para 0116; the angle can be 90°).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Farhangnia (US 2014/0207179) in view of Gianotti (US 2013/0237950) and further in view of Boyle (US 2003/0028210).
Regarding Claim 20, the modified invention of Farhangnia and Gianotti discloses all of the elements of the inventing as discussed above, however, is silent regarding said balloon member is formed with a radiopaque material loaded balloon material fabricated with a plurality of micro pores, said radiopaque material being selected from a group including tungsten, barium, gold, and combination thereof.
Boyle teaches an analogous balloon member (50, Fig 4) wherein the balloon member is formed with a radiopaque material loaded balloon material fabricated with a plurality of micro pores (56, Fig 4), said radiopaque material being selected from a group including tungsten, barium, gold, and combination thereof (Para 0023-0024).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ballon to include micro pores and be made of radiopaque material including gold as taught by Boyle in order to affect a specific perfusion pattern and enhance visualization of the balloon under x-ray (Para 0024, 0029)
Regarding Claim 21, the modified invention of a Farhangnia, Gianotti, and Boyle discloses a medicinal fluid delivered into the balloon member through said inflation lumen, wherein said medicinal fluid exits from said balloon member through said plurality of micro pores (Para 0029 -Boyle).
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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