DETAILED ACTION
This Office Action is in response to the Amendment filed 11 December 2025. Claim(s) 1 and 3-21 are currently pending. The Examiner acknowledges the amendments to claim(s) 1, 6-8, 10, 11, 16, 17 and 21, cancelled claim(s) 2.
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 .
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
guiding member in claim 1
expandable members in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 8 is objected to because of the following informalities: please change “a iliac” in line 2 to “an iliac”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: please change “the non-inflated state” in part b to “a non-inflated state”. Appropriate correction is required.
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) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ravikumar (US 2011/0034948A1) in view of von Segesser (US 2018/0243536A1) in view of Rasmusson (US 2015/0105816A1).
Regarding claims 1, 3 and 10, Ravikumar discloses an elongated hollow housing (102; Fig. 2A) having a distal end capable of being placed within an artery or vasculature of a patient and approximal end capable of remaining outside a body of a patient (Fig. 3). The hollow housing is a catheter [0014] having a diameter of about 5 French to about a 9 French ([0014], within a range of 7-9french). The length of the catheter shaft is at least 80cm [0014, 0032]. A plurality of expandable members/balloons (104, [0028], Fig. 2A) are located proximally from the distal end of the hollow housing and are capable of occluding a portion of an artery or vasculature of a patient and spaced from one another on the hollow housing so as to occlude such artery or vasculature. Each balloon is connected to a separate inflation lumen (114; [0030]) within the elongated hollow housing. An inflation port (108) is connected to the proximal end of the elongated hollow housing and fluidly connected to each separate lumen connected to each balloon [0028-0031]. Ravikumar discloses that guidewires may pass through a main lumen (112; [0031]) of the hollow housing but does not disclose a guidewire or an inflation source within the inflation port.
In the same field of endeavor, guiding members, von Segesser teaches a guide wire (202; Fig. 2) disposed within a catheter/hollow housing in a straight configuration [0085-0087]. The guide wire may be formed of nitinol [0086]. When activated and extended out of the distal end of the hollow housing, the distal portion of the guide wire includes coils (208) that are capable of being pushed or guided within the vasculature of the inner walls of the anchoring location/target artery, thereby creating a friction fit structure that prevents the guide wire from moving in and out of the anchoring location, thus preventing migration into a branched vessel [0085-0098]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the instrument of Ravikumar with a guiding member, as taught by von Segesser, for the predictable result of providing means for guidance assistance to a target location and means for preventing migration. With this modification, when activated outside of the distal end of the hollow housing, the guide wire has a wider diameter in the perpendicular vertical axis compared to the horizontal axis of the guidewire and the hollow housing [0089].
In the same field of endeavor, balloon catheters, Rasmusson teaches a catheter device that includes an elongated hollow housing (10; Fig. 1) having a distal end capable of being placed within an artery or vasculature of a patient and proximal end capable of remaining outside a body of a patient. A plurality of balloons (20, [0012,0015, 0018], Fig. 1), wherein each balloon is connected to a separate inflation lumen [0015] within the elongated hollow housing. Each lumen is connected to an inflation source (15;[0013]) at the proximal end of the separate lumen. An inflation port is connected to the proximal end of the elongated hollow housing and fluidly connected to each separate lumen connected to each balloon [0010, 0013]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the catheter of Ravikumar with an inflation source, as taught by Rasmusson, for the predictable result of providing means for inflating the balloons.
Regarding claim 4, the combination of Ravikumar, von Segesser and Rasmusson discloses that the plurality of expandable members is at least three and in the range of 3 to 10 (Fig. 2A; [0014]; Ravikumar).
Regarding claim 5, the combination of Ravikumar, von Segesser and Rasmusson discloses that the plurality of expandable members are catheter balloons in the shape of circles, ovals, tubes, rectangles or other geometric shapes (Fig. 2A; Ravikumar) and have a diameter of about 0.5cm to about 5.0cm when inflated ([0014], 2.5cm; Ravikumar).
Regarding claims 6 and 7, the combination of Ravikumar, von Segesser and Rasmusson discloses that the expandable members are located at a distal portion of the catheter and are at least 2.5cm in diameter [0014]. The proximal-most and distal-most expandable members are spaced apart at a distance between 20cm and 40cm (abs; Ravikumar), thus the expandable members are spaced at least 40 cm from the most proximal portion of the hollow housing where the inflation port is located ([0014];Fig. 2A; Ravikumar). Spacing between adjacent balloons is regular at a distance of approximately 10cm [0028; Ravikumar] which is within the claimed range of about 10cm to about 40cm.
Regarding claim 8, the combination of Ravikumar, von Segesser and Rasmusson discloses that the location of the plurality of expandable members is capable of occluding a chosen artery or an iliac bifurcation when in the inflated state [0012] with the chosen arteries selected from the group consisting of the renal artery, aortic artery, thoracic artery, abdominal artery, celiac artery, superior mesenteric artery, inferior mesenteric artery, left common iliac artery, left internal iliac artery, left external iliac artery, right common iliac artery, right internal iliac artery, right external iliac artery, left femoral artery, right femoral artery and combinations thereof [0036, 0056; Ravikumar].
Regarding claim 9, the combination of Ravikumar, von Segesser and Rasmusson discloses that the guiding member is an expandable member capable of having two inflation states. The first inflation state is smaller (straightened) so that the guiding member guides the distal end of the hollow housing within the artery and the second inflation state being larger (expanded) so that the guiding member expands to occlude the artery or vasculature (Fig. 2; [0085-0087]; von Segesser).
Regarding claim 11, the combination of Ravikumar, von Segesser and Rasmusson discloses that the plurality of balloons is from 2 to 7 [0014; Ravikumar] and the first balloon is adapted to be capable of having an inflated state to selectively occlude blood flow from the iliac arteries [0038; Ravikumar].
Regarding claim 12, the combination of Ravikumar, von Segesser and Rasmusson discloses that the plurality of balloons are catheter balloons in the shape of circles, ovals, tubes, rectangles or other geometric shapes (Fig. 2A; Ravikumar) and have a diameter of about 0.5cm to about 5.0cm when inflated ([0014], 2.5cm; Ravikumar).
Regarding claim 13, the combination of Ravikumar, von Segesser and Rasmusson discloses that a balloon diameter in the inflated state is about 1.5cm to about 3.0cm ([0014, 0028], 2.5cm; Ravikumar).
Regarding claim 14, the combination of Ravikumar, von Segesser and Rasmusson discloses that the plurality of expandable members is spaced apart from each other on the hollow housing at a distance of about 1cm to about 60cm from each other [0028; Ravikumar]. Spacing between adjacent balloons is regular at a distance of approximately 10cm [0028; Ravikumar].
Regarding claim 15, the combination of Ravikumar, von Segesser and Rasmusson discloses that the spacing of each of the plurality of expandable members/balloons is capable of occluding a chosen artery or the iliac bifurcation when in the inflated state [0012] with the chosen arteries selected from the group consisting of the renal artery, aortic artery, thoracic artery, abdominal artery, celiac artery, superior mesenteric artery, inferior mesenteric artery, left common iliac artery, left internal iliac artery, left external iliac artery, right common iliac artery, right internal iliac artery, right external iliac artery, left femoral artery, right femoral artery and combinations thereof [0036, 0056; Ravikumar].
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ravikumar (US 2011/0034948A1) in view of Martin (US 2016/0228684A1) in view of Rasmusson (US 2015/0105816A1).
Regarding claims 1, 3 and 10, Ravikumar discloses an elongated hollow housing (102; Fig. 2A) having a distal end capable of being placed within an artery or vasculature of a patient and approximal end capable of remaining outside a body of a patient (Fig. 3). The hollow housing is a catheter [0014] having a diameter of about 5 French to about a 9 French ([0014], within a range of 7-9french). The length of the catheter shaft is at least 80cm [0014, 0032]. A plurality of expandable members/balloons (104, [0028], Fig. 2A) are located proximally from the distal end of the hollow housing and are capable of occluding a portion of an artery or vasculature of a patient and spaced from one another on the hollow housing so as to occlude such artery or vasculature. Each balloon is connected to a separate inflation lumen (114; [0030]) within the elongated hollow housing. An inflation port (108) is connected to the proximal end of the elongated hollow housing and fluidly connected to each separate lumen connected to each balloon [0028-0031]. Ravikumar discloses that guidewires may pass through a main lumen (112; [0031]) of the hollow housing but does not disclose a guidewire or an inflation source within the inflation port.
In the same field of endeavor, guiding members, Martin teaches a guiding member is a guidewire (102/104; Fig. 5A) disposed within a catheter/hollow housing (12) in a compressed or non-activated flat state [0071]. The guidewire may include nitinol [0085, 0078]. When activated and extended out of the distal end of the hollow housing, the distal portion of the guide wire includes a geometric shape (104; Fig. 5B) that is capable of guiding the elongated hollow housing within the vasculature to a target artery without migrating into non-target arteries. When activated, the guidewire has a wider diameter in the perpendicular vertical axis compared to the horizontal axis of the guidewire and hollow housing. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the instrument of Ravikumar with a guiding member, as taught by Martin, for the predictable result of providing means for guidance assistance to a target location and means for preventing migration. With this modification, when activated outside of the distal end of the hollow housing, the guide wire has a wider diameter in the perpendicular vertical axis compared to the horizontal axis of the guidewire and the hollow housing [0089].
In the same field of endeavor, balloon catheters, Rasmusson teaches a catheter device that includes an elongated hollow housing (10; Fig. 1) having a distal end capable of being placed within an artery or vasculature of a patient and proximal end capable of remaining outside a body of a patient. A plurality of balloons (20, [0012,0015, 0018], Fig. 1), wherein each balloon is connected to a separate inflation lumen [0015] within the elongated hollow housing. Each lumen is connected to an inflation source (15;[0013]) at the proximal end of the separate lumen. An inflation port is connected to the proximal end of the elongated hollow housing and fluidly connected to each separate lumen connected to each balloon [0010, 0013]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the catheter of Ravikumar with an inflation source, as taught by Rasmusson, for the predictable result of providing means for inflating the balloons.
Regarding claim 4, the combination of Ravikumar, Martin and Rasmusson discloses that the plurality of expandable members is at least three and in the range of 3 to 10 (Fig. 2A; [0014]; Ravikumar).
Regarding claim 5, the combination of Ravikumar, Martin and Rasmusson discloses that the plurality of expandable members are catheter balloons in the shape of circles, ovals, tubes, rectangles or other geometric shapes (Fig. 2A; Ravikumar) and have a diameter of about 0.5cm to about 5.0cm when inflated ([0014], 2.5cm; Ravikumar).
Regarding claims 6 and 7, the combination of Ravikumar, Martin and Rasmusson discloses that the expandable members are located at a distal portion of the catheter and are at least 2.5cm in diameter [0014]. The proximal-most and distal-most expandable members are spaced apart at a distance between 20cm and 40cm (abs; Ravikumar), thus the expandable members are spaced at least 40 cm from the most proximal portion of the hollow housing where the inflation port is located ([0014];Fig. 2A; Ravikumar). Spacing between adjacent balloons is regular at a distance of approximately 10cm [0028; Ravikumar] which is within the claimed range of about 10cm to about 40cm.
Regarding claim 8, the combination of Ravikumar, Martin and Rasmusson discloses that the location of the plurality of expandable members is capable of occluding a chosen artery or an iliac bifurcation when in the inflated state [0012] with the chosen arteries selected from the group consisting of the renal artery, aortic artery, thoracic artery, abdominal artery, celiac artery, superior mesenteric artery, inferior mesenteric artery, left common iliac artery, left internal iliac artery, left external iliac artery, right common iliac artery, right internal iliac artery, right external iliac artery, left femoral artery, right femoral artery and combinations thereof [0036, 0056; Ravikumar].
Regarding claim 9, the combination of Ravikumar, Martin and Rasmusson discloses that the guiding member is an expandable member capable of having two inflation states. The first inflation state is smaller (straightened) so that the guiding member guides the distal end of the hollow housing within the artery and the second inflation state being larger (expanded) so that the guiding member expands to occlude the artery or vasculature (Fig. 2; [0085-0087]; von Segesser).
Regarding claim 11, the combination of Ravikumar, Martin and Rasmusson discloses that the plurality of balloons is from 2 to 7 [0014; Ravikumar] and the first balloon is adapted to be capable of having an inflated state to selectively occlude blood flow from the iliac arteries [0038; Ravikumar].
Regarding claim 12, the combination of Ravikumar, Martin and Rasmusson discloses that the plurality of balloons are catheter balloons in the shape of circles, ovals, tubes, rectangles or other geometric shapes (Fig. 2A; Ravikumar) and have a diameter of about 0.5cm to about 5.0cm when inflated ([0014], 2.5cm; Ravikumar).
Regarding claim 13, the combination of Ravikumar, Martin and Rasmusson discloses that a balloon diameter in the inflated state is about 1.5cm to about 3.0cm ([0014, 0028], 2.5cm; Ravikumar).
Regarding claim 14, the combination of Ravikumar, Martin and Rasmusson discloses that the plurality of expandable members is spaced apart from each other on the hollow housing at a distance of about 1cm to about 60cm from each other [0028; Ravikumar]. Spacing between adjacent balloons is regular at a distance of approximately 10cm [0028; Ravikumar].
Regarding claim 15, the combination of Ravikumar, Martin and Rasmusson discloses that the spacing of each of the plurality of expandable members/balloons is capable of occluding a chosen artery or the iliac bifurcation when in the inflated state [0012] with the chosen arteries selected from the group consisting of the renal artery, aortic artery, thoracic artery, abdominal artery, celiac artery, superior mesenteric artery, inferior mesenteric artery, left common iliac artery, left internal iliac artery, left external iliac artery, right common iliac artery, right internal iliac artery, right external iliac artery, left femoral artery, right femoral artery and combinations thereof [0036, 0056; Ravikumar].
Allowable Subject Matter
Claim(s) 16-21 are allowed. The prior art of record does not disclose or suggest a method of guiding a catheter device within a vasculature of a patient, the method including providing a catheter device including an elongated hollow housing, a guidewire including a memory material configured to be inserted within a lumen of the elongated hollow housing in a non-activated flat state and once outside the lumen and distal end of the hollow housing activated into a second state in a shape of either a coil, spiral, corkscrew, circle or other geometric shapes, a plurality of balloons with each balloon connected to a separate lumen within the elongated hollow housing with each lumen connected to an inflation source and an inflation port connected to the distal end of the hollow housing and fluidly connected to each separate lumen, advancing the catheter device with the guidewire in the activated state and the balloons in a non-inflated state, through the vasculature of a patient such that the distal balloon is positioned at a target artery, inflating the distal balloon at the location of the target artery to isolate or occlude blood flow at the target artery and withdrawing the guidewire from within the hollow housing out of the patient, in combination with the other claimed limitations.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 3-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kurosawa et al. (US 2012/0029478A1) discloses a guide wire that includes a j-shaped distal end that is capable of being advanced through vasculature and avoiding branched vessels.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771