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 .
Election/Restrictions
Applicants’ election without traverse of Group I in the reply filed on 09/18/2026 is acknowledged. Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim.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.
Claim(s) 1-7 and 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saatchi et al. (US 2016/0331935).
Regarding claim 1, Saatchi et al. discloses a delivery apparatus comprising (10, FIG 1-3): a handle (16, FIG 1 and 4, [0031-0034]) comprising: a proximal segment (56) including one or more fluid seals (50, FIG 4) mounted within the proximal segment (FIG 4), the fluid seals configured to allow insertion of a device into the handle and prevent fluid flow past the fluid seals ([0035], FIG 10); an intermediate segment (58) disposed adjacent and distal to the proximal segment (FIG 4), the intermediate segment including an inner surface defining a first lumen (lumen 64, see inner surface in FIG 4), wherein the first lumen has a first inner diameter (Diameter taken at the position of 74, FIG 4), wherein the first lumen includes an inlet (at the surface which abuts 50, or alternatively, as annotated below) and an outlet (See annotated FIG 4 below); and a distal segment (54) disposed adjacent and distal to the intermediate segment (FIG 4); and a shaft (11) extending distally from the handle (FIG 1-4), the shaft including a distal end (As shown in FIG 1-3), a proximal end (End shown in FIG 4), and a second lumen (13, [0035]) extending between the distal end and the proximal end of the shaft (FIG 4), wherein the proximal end of the shaft is disposed within the distal segment of the handle (FIG 4, see 11 being inserted within 54) and is coupled to the outlet of the first lumen (FIG 4), wherein the second lumen includes a second inner diameter (constant diameter of 13 shown in FIG 4) that is smaller than the first inner diameter of the first lumen (The diameter of 13 forms the narrowest portion of the lumen pathway and is smaller than the first inner diameter).
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Regarding claim 2, Saatchi et al. discloses the first lumen and the second lumen are coaxial (See coaxial alignment in FIG 4).
Regarding claim 3, Saatchi et al. discloses the inlet of the first lumen is coupled to the proximal segment of the handle (Via direct connection to 50 which forms a part of the proximal segment).
Regarding claim 4, Saatchi et al. discloses the inner surface includes at least one taper (see tapered region in FIG 4).
Regarding claim 5, Saatchi et al. discloses the inner surface includes a band having a constant inner diameter equal to the first inner diameter (See annotated FIG 5 above, or in the alterative as annotated above).
Regarding claim 6, Saatchi et al. discloses the band extends from the inlet of the first lumen to the outlet of the first lumen (See in the alternative interpretation of the band/inlet above where the band extends from the inlet to the outlet of the first lumen).
Regarding claim 7, Saatchi et al. discloses the band includes a distal end (Left end as viewed in FIG 4) and a proximal end (Right end as viewed in FIG 4), wherein the inner surface is tapered from the distal end of the band to the outlet of the first lumen (FIG 4).
Regarding claim 10, Saatchi et al. discloses a flush port (18, [0034]) coupled to the intermediate segment (FIG 4), the flush port fluidly coupled to the first lumen via a flush lumen (62, [0034]).
Regarding claim 11, Saatchi et al. discloses an inner diameter of the outlet of the first lumen is equal to the second inner diameter (FIG 4).
Regarding claim 12, Saatchi et al. discloses an inner diameter of the inlet of the first lumen is equal to the second inner diameter (In the alternative interpretation of the inlet, the inner diameter at the inlet is equal to the second diameter, FIG 4).
Regarding claim 13, Saatchi et al. discloses a delivery assembly comprising: an implant catheter (30. [0033], FIG 2); and a guide catheter (10, FIG 1-2) comprising: a shaft (11)having a distal end (14) and a proximal end (End shown in FIG 4), the shaft including a main lumen (13) configured to receive a portion of the implant catheter therethrough (FIG 2, [0032]), the main lumen having a first inner diameter (Inner diameter shown in FIG 4); and a handle (16, FIG 1 and 4, [0031-0034]) including a reservoir (Lumen of 64) coupled to the proximal end of the shaft (FIG 4) and a seal housing assembly (56, which houses seal 50) adjacent and proximal to the reservoir (FIG 4), the reservoir including a reservoir lumen in fluid communication with the main lumen (FIG 4), the reservoir lumen having a second inner diameter that is larger than the first inner diameter (Diameter at the tapered proximal end which is larger than the diameter of 13), wherein the seal housing assembly includes one or more fluid seals (50) mounted within the seal housing assembly (FIG 4) and configured to allow insertion of the implant catheter therethrough ([0035], FIG 10).
Regarding claim 14, Saatchi et al. discloses the reservoir lumen is coaxial with the main lumen (See coaxial alignment in FIG 4).
Regarding claim 15, Saatchi et al. discloses the proximal end of the shaft is disposed within the handle (FIG 4, see 11 being inserted within 54).
Claim(s) 1-5 and 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osborne et al. (US 2005/0192537).
Regarding claim 1, Osborne et al. discloses a delivery apparatus comprising (FIG 3): a handle (10, FIG 1-2, [0040-0042) comprising: a proximal segment (17) including one or more fluid seals (1, [0043-0045], FIG 2) mounted within the proximal segment (FIG 1), the fluid seals configured to allow insertion of a device into the handle and prevent fluid flow past the fluid seals ([0044-0045]); an intermediate segment (12 and 32, FIG 1-2, [0040-0041]) disposed adjacent and distal to the proximal segment (FIG 1), the intermediate segment including an inner surface defining a first lumen (lumen 11, see inner surface in FIG 1), wherein the first lumen has a first inner diameter (Diameter taken at the position of 11 in between 71 and 72, FIG 1), wherein the first lumen includes an inlet (See annotated FIG 1 below) and an outlet (See annotated FIG 1 below); and a distal segment (51) disposed adjacent and distal to the intermediate segment (FIG 1); and a shaft (35) extending distally from the handle (FIG 1 and 3), the shaft including a distal end (As shown in FIG 3), a proximal end (36, [0041), and a second lumen (FIG 1-2 show lumen of 35) extending between the distal end and the proximal end of the shaft (So as to receive dilator 56 as shown in FIG 3), wherein the proximal end of the shaft is disposed within the distal segment of the handle (FIG 1-2) and is coupled to the outlet of the first lumen (FIG 1), wherein the second lumen includes a second inner diameter (constant inner diameter of 35 shown in FIG 1) that is smaller than the first inner diameter of the first lumen (The diameter of 35 forms the narrowest portion of the lumen pathway and is smaller than the first inner diameter).
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Regarding claim 2, Osborne et al. discloses the first lumen and the second lumen are coaxial (See coaxial alignment in FIG 1).
Regarding claim 3, Osborne et al. discloses the inlet of the first lumen is coupled to the proximal segment of the handle (Via direct connection between threads 15 and 19, [0040]).
Regarding claim 4, Osborne et al. discloses the inner surface includes at least one taper (Taper 71 and 72, [0072).
Regarding claim 5, Osborne et al. discloses the inner surface includes a band having a constant inner diameter equal to the first inner diameter (length of 11 extending between 71 and 72, and having a constant diameter).
Regarding claim 7, Osborne et al. discloses the band includes a distal end (Right end as viewed in FIG 1) and a proximal end (Left end as viewed in FIG 1), wherein the inner surface is tapered from the distal end of the band to the outlet of the first lumen (Along taper 72).
Regarding claim 8, Osborne et al. discloses the inner surface includes a step disposed between the inlet of the first lumen and the proximal end of the band (Taper 71 is interpreted as the step between the inlet and the proximal end of the band).
Regarding claim 9, Osborne et al. discloses the inner surface is tapered from the proximal end of the band to the inlet of the first lumen (Along taper 71).
Regarding claim 10, Osborne et al. discloses a flush port (45, [0042]) coupled to the intermediate segment (FIG 1), the flush port fluidly coupled to the first lumen via a flush lumen (See lumen in projection 47, [0042]).
Regarding claim 11, Osborne et al. discloses an inner diameter of the outlet of the first lumen is equal to the second inner diameter (FIG 1).
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.
Claim(s) 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Saatchi et al. (US 2016/0331935) in view of Jimenez et al. (US 2011/0015729).
Regarding claims 16-17, Saatchi disclseos the invention substantially as claimed, as set forth above for claim 13. Saatchi further discloses that the implant catheter/dilator 30 provides access to interventional devices which are passed through the lumen of dilator 30 and out its distal portion 32 and distal opening 39 and thereafter into the accessed blood vessel ([0033]).
Saatchi is silent regarding the implant catheter specifically comprising a prosthetic heart valve coupled to the implant catheter.
However, Jimenez discloses in the same field of endeavor a guide catheter (100, FIG 6A and 13) and an implant device (54/140, FIG 13, [0064-0065]) which comprises a prosthetic heart valve (50, [0097-0100]), wherein the implant device is inserted through the lumen of the guide catheter (FIG 14A) for delivery to the treatment site ([0100]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the delivery assembly of Saatchi to comprise a prosthetic heart valve coupled to the implant catheter, as taught by Jimenez, for the purpose of a selecting an interventional device commonly known in the art to be used with a guide catheter and thereby achieving the predictable result of delivering a prosthetic heart valve to perform a desired treatment in a fluidly sealed manner ([0065]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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