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 .
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 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.
Response to Amendment
The Response filed January 5, 2026 has been entered. Claims 1-9 and 11-16 are pending in the application. The previous rejections of claims under 35 U.S.C. § 112(a) are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
Claim Objections
Claims 14-16 are objected to because of the following informalities:
Claim 14, line 1, the phrase “autraumatic pigtail” should read - - atraumatic pigtail - -.
Claim 15, line 1, the phrase “autraumatic pigtail” should read - - atraumatic pigtail - -.
Claim 16, line 1, the phrase “autraumatic pigtail” should read - - atraumatic pigtail - -.
Claim 16, line 1, the phrase “has a a total length” should read - - has a total length - -.
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 1-9 and 11-16 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 limitations “the cone” (line 9) and “the prosthetic valve” (line 11). There is insufficient antecedent basis for these limitations in the claim because the claim lacks a prior recitation of a cone or prosthetic valve.
Claim 1 recites the limitations “balloon anchoring mechanisms” (line 10-11) and “at least one anchoring mechanism” (lines 13-14). The claim is unclear whether these “anchoring mechanisms” refer to the same anchoring mechanism or different ones, thus rendering the claim indefinite. For examination purposes, the claim is interpreted as referring to the same anchoring mechanism.
Claims 2-9 and 11-16 are rejected as being dependent upon rejected claim 1 and failing to remedy the indefiniteness issue.
Claim 2 depends from claim 1 and recites the limitation “a cone” in line 3. The claim is unclear whether this cone refers to the cone recited in claim 1 or a different one, thus rendering the claim indefinite. For examination purposes, the claim is interpreted as referring to the same cone.
Claim 15 recites the limitations “the curled end” (line 2) and “the straight portion of the pigtail” (line 2). There is insufficient antecedent basis for these limitations in the claim because the claim lacks a prior recitation of a curled end or a straight portion.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-9, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Tilson et al. (U.S. Patent Application Publication No. 20130190796; hereinafter “Tilson”) in view of Tan et al. (U.S. Patent Application Publication No. 20090182412; hereinafter “Tan”), Lampropoulos et al. (U.S. Patent Application Publication No. 20150283357; hereinafter “Lampropoulos”); Weldon (U.S. Patent No. 5088991); Madrid et al. (U.S. Patent Application Publication No. 20110144742; hereinafter “Madrid”), and Drasler et al. (U.S. Patent Application Publication No. 20120083809; hereinafter “Drasler”).
Regarding claim 1, Tilson discloses a delivery system (10) for implants (12) used in structural heart diseases by a minimally invasive method (para. [0090]) comprising:
a single balloon (20);
a catheter (2000) connected with a distal section of the balloon (annotated Fig. 1B below)
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and on a side of the catheter with a straight cap (634; annotated Fig. 60 below) having a lateral canal to which a pressure syringe for pumping the single balloon is attached, and wherein inside the single balloon and in the catheter, there is a canal (154a) extending to outside of the single balloon having a single wall (Fig. 1B; para. [0144]).
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The delivery system of Tilson discloses the invention substantially as claimed, except for an exterior surface of the catheter being covered with a special shield. Tan, a reference in the stent delivery field of endeavor, teaches providing a delivery system with a special shield (20) covering a catheter (10; Fig. 2A) to limit axial movement of a stent relative to the catheter (paras. [0035] and [0037]-[0040]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the delivery system of Tilson with a special shield such that an exterior surface of the catheter is covered with the special shield, in view of Tan, to improve accurate placement of an implant by limiting movement of the stent.
The modified device discloses the invention substantially as claimed, except for the catheter including an atraumatic pigtail extending from a cone at the distal end of the catheter.
Lampropoulos, a reference in the vascular catheter field of endeavor, teaches providing a device delivery catheter with an atraumatic pigtail (150) extending from a cone (124) at the distal end of the catheter, the pigtail comprising a coil-shaped tube (158; Fig. 1), wherein the coil operates to facilitate atraumatic advancement within a patient (para. [0028]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the catheter with an atraumatic pigtail extending from the cone at the distal end of the catheter, the pigtail comprising a coil-shaped tube, wherein the coil operates to protect the left ventricle from damage, in view of Lampropoulos, in order to facilitate advancing the catheter to a treatment site without harming the patient.
The modified device discloses the invention substantially as claimed, except for the pigtail including a coil-shaped polyamide tube. Weldon, a reference in the vascular catheter field of endeavor, teaches forming a pigtail (col. 3, ln. 52 – col. 4, ln. 4) from a coil-shaped polyamide tube to provide the atraumatic tip with soft, flexible properties (col. 4, ll. 40-62). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the pigtail to comprise a coil-shaped polyamide tube, in view of Weldon, in order to provide the pigtail with soft, flexible properties to facilitate atraumatic advancement of the catheter to a treatment site without harming the patient.
The modified device discloses the invention substantially as claimed, except for including at least one anchoring mechanism comprising the single balloon having a dog-bone shape when expanded.
However, Tilson teaches configuring a single wall balloon (20) to have a dog-bone shape (Figs. 13A-13C; paras. [0222]-[0223]).
Also, Madrid teaches providing a delivery system with at least one anchoring mechanism adapted to deploy a single balloon having a single wall (“single outer balloon member” (198); Figs. 19A-19B; para. [0137]), the anchoring mechanism comprising the single balloon (198) having a dog-bone shape when expanded (Fig. 19B), an area for the balloon of the exterior of the catheter defined by two protrusions at distal and proximal ends of the balloon having a larger diameter than a middle balloon area (annotated Fig. 19B below) to stabilize a prosthetic device on the delivery system (paras. [0135], [0137]).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified delivery system with at least one anchoring mechanism comprising the balloon having a dog-bone shape when expanded, an area for the balloon of the exterior of the catheter defined by two protrusions at distal and proximal ends of the balloon having a larger diameter than a middle balloon area, in view of Tilson and Madrid, in order to prevent undesired movement of a valve implant on the delivery system during a procedure.
The modified device further discloses wherein the coil is capable of cooperating with balloon anchoring mechanisms to stabilize the prosthetic valve (Madrid paras. [0135], [0137]) and simultaneously protect the left ventricle from damage (Lampropoulos para. [0028]).
The modified device discloses the invention substantially as claimed, except for the single balloon being adapted to be filled in three phases, first the distal protrusion is filled, in a second phase the proximal protrusion of the single balloon is filled, and in a third phase, the middle of the single balloon is filled.
However, Madrid teaches that the single balloon (198) is adapted to be filled in multiple phases (Figs. 19B-19C) with the proximal and distal portions being filled first (Fig. 19B) and the middle portion of the single balloon (198) being filled last (Fig. 19C; para. [0137]) to secure a prosthetic device for delivery (para. [0137]).
Drasler, a reference in the valvuloplasty catheter field of endeavor, teaches configuring a balloon such that first a distal protrusion is filled and in a second phase the proximal protrusion of the balloon is filled (Figs. 1A-1C; para. [0051]) in order to help position a balloon within a valve for treatment (para. [0025]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the single balloon to be filled in three phases, first the distal protrusion is filled, in a second phase the proximal protrusion of the single balloon is filled, in view of Drasler, and in a subsequent third phase, the middle of the single balloon is filled, as taught by Madrid, in order to facilitate accurate positioning of the delivery system to treat a heart valve.
Regarding claim 2, the modified delivery system discloses wherein an anchoring mechanism (cone (124); Fig. 1 of Lampropoulos) is placed on the straight section of the atraumatic pigtail (Fig. 1 of Lampropoulos shows the pigtail including a straight portion where it connects with tapered region (124) of the catheter) at an intersection with a proximal part of the single balloon (Examiner interprets the term “proximal part of the balloon” broadly to include a portion of the balloon leading to the position of the cone in the modified device) and comprises a cone (124) whose widened part is directed at the single balloon.
Regarding claim 3, the modified delivery system discloses wherein the anchoring mechanism comprises an additional protrusion (192; Fig. 19B of Madrid) of the canal inside the single balloon (198; Fig. 19B of Madrid) adapted to facilitate different filling of distal and proximal ends of the single balloon (proximal balloon protrusion is configured for different filling than the distal protrusion; paras. [0025]-[0027] of Drasler).
Regarding claim 4, the modified delivery system discloses wherein the single balloon having a dog-bone shape is adapted to be deployed at a proximal end of the shield of the catheter (Figs. 2A-2B of Tan), wherein the shield is in the form of a sheath which increases in size from proximal direction of the sheath to distal direction of the sheath (Figs. 4-7 of Tan show the end (21a, 22a, 23a, 24a) getting bigger).
Regarding claim 6, Tan discloses the anchoring systems comprises a sheath (21a, 22a, 23a, or 24a; Figs. 4-7) at an end of the shield formed like a cone dilation in the direction of the distal end of the single balloon (Figs. 4-7 show different forms of a sheath proximal end formed like a cone dilation).
Regarding claim 7, Lampropoulos discloses wherein the pigtail is a pipe adapted for delivering a solution (paras. [0028]-[0029]).
Regarding claim 8, Madrid discloses wherein the middle single balloon area is adapted to form an even exterior profile with the distal and proximal protrusion (annotated Figs. 19B-19C below).
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Regarding claim 9, Lampropoulos discloses wherein the pigtail is adapted to prevent trauma (para. [0028]).
Regarding claim 11, the modified delivery system discloses wherein the middle single balloon area is adapted to receive a stent (para. [0137] of Madrid).
Regarding claim 12, the modified delivery system discloses wherein the middle single balloon area is adapted to have an even profile with the protrusions upon filling (Fig. 19C of Madrid).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tilson in view of Tan, Lampropoulos, Weldon, Madrid, and Drasler, as applied to claim 1 above, and further in view of Ellis et al. (U.S. Patent No. 6395008; hereinafter “Ellis”).
Regarding claim 5, the modified delivery system discloses the invention substantially as claimed, except for the anchoring mechanism comprising markers. Ellis, a reference in the stent delivery device field of endeavor, teaches providing a delivery system with markers (collars (74) may be made of radiopaque material; Fig. 8; col. 7, ll. 7-10) placed on the outside surface of a canal (72) whose diameter is bigger than the diameter of the canal (Figs. 8 and 9) to help secure an implant to a balloon (col. 6, ll. 27-33). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the anchoring mechanism with markers placed on the outside surface of the canal whose diameter is bigger than a diameter of the canal, in view of Ellis, in order to better secure the implant on the modified delivery system.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tilson in view of Tan, Lampropoulos, Weldon, Madrid, and Drasler, as applied to claim 1 above, and further in view of Macoviak et al. (WO9915223; hereinafter “Macoviak”).
Regarding claim 13, the modified delivery system discloses the invention substantially as claimed, except for the atraumatic pigtail including a coil having a turn and a half.
Macoviak, a reference in the heart valve treatment field of endeavor, teaches configuring an atraumatic pigtail (4370; Fig. 43) to include a coil having a turn and a half to protect adjacent tissue from damage during a procedure (pg. 41, ll. 5-14).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention configure the atraumatic pigtail to include a coil having a turn and a half and be adapted to protect the left ventricle against damage, in view of Macoviak, in order to prevent harming tissue of the left ventricle during a procedure.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tilson in view of Tan, Lampropoulos, Weldon, Madrid, and Drasler, as applied to claim 1 above, and further in view of Magrini (U.S. Patent No. 4153048).
Regarding claim 14, the modified device discloses the invention substantially as claimed, except for the atraumatic pigtail having a diameter between 21 and 31 mm.
Lampropoulos teaches that length and bends of the pigtail may be altered to facilitate insertion and/or guidance of a catheter within a patient (para. [0071]).
Magrini, a reference in the vascular catheter field of endeavor, teaches configuring the dimensions of a pigtail to fit within a blood vessel (col. 7, ll. 36-60).
Thus, a person having ordinary skill in the art would recognize the diameter of the pigtail to be a result-effective variable for an atraumatic catheter fitting within a desired blood vessel.
Further, it appears that a person having ordinary skill in the art would have had a reasonable expectation of success in modifying the pigtail of the modified device to have a diameter within the claimed range, as it involves only adjusting the dimension of the pigtail.
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 device by providing the pigtail with a diameter between 21 and 31 mm as a matter of routine optimization to fit the pigtail to the vasculature of the patient to be treated and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 15, the modified device discloses the invention substantially as claimed, except for the atraumatic pigtail having a distance of 24.5mm between the outermost portion of the curled end and the straight portion of the pigtail.
Lampropoulos teaches that length and bends of the pigtail may be altered to facilitate insertion and/or guidance of a catheter within a patient (para. [0071]).
Magrini, a reference in the vascular catheter field of endeavor, teaches configuring the dimensions of a pigtail to fit within a blood vessel (col. 7, ll. 36-60).
Thus, a person having ordinary skill in the art would recognize the length of the pigtail to be a result-effective variable for an atraumatic catheter fitting within a desired blood vessel.
Further, it appears that a person having ordinary skill in the art would have had a reasonable expectation of success in modifying the pigtail of the modified device to have a length of the claimed value, as it involves only adjusting the dimension of the pigtail.
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 device by providing the pigtail with a distance of 24.5mm between the outermost portion of the curled end and the straight portion of the pigtail as a matter of routine optimization to fit the pigtail to the vasculature of the patient to be treated and since it has been held that discovering an optimum value of a result effective variable is ordinarily within the skill of the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 16, the modified device discloses the invention substantially as claimed, except for the atraumatic pigtail having a total length between 40mm and 60mm.
Lampropoulos teaches that length and bends of the pigtail may be altered to facilitate insertion and/or guidance of a catheter within a patient (para. [0071]).
Magrini, a reference in the vascular catheter field of endeavor, teaches configuring the dimensions of a pigtail to fit within a vessel (col. 7, ll. 36-60).
Thus, a person having ordinary skill in the art would recognize the total length of the pigtail to be a result-effective variable for an atraumatic catheter fitting within a desired blood vessel.
Further, it appears that a person having ordinary skill in the art would have had a reasonable expectation of success in modifying the pigtail of the modified device to have a total length within the claimed range, as it involves only adjusting the dimension of the pigtail.
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 device by providing the pigtail with a total length between 40mm and 60mm as a matter of routine optimization to fit the pigtail to the vasculature of the patient to be treated and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments with respect to claim 1 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. Specifically, Applicant’s arguments only discuss the Crittenden reference, which is no longer relied upon to rejected the claims.
Conclusion
Applicant's amendment necessitated any 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/J.A.H/Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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