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
Applicant’s election without traverse of Group II, claims 9-14 in the reply filed on 07/26/2026 is acknowledged. Claims 1-8 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected advancer and method of delivering a medical device, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/26/2026.
Specification
The disclosure is objected to because of the following informalities: In paragraph [0077] the introducer hub is cited as “introducer hub 352” and “introducer hub 310”. It is assumed that “introducer hub 310” is a typo. Appropriate correction is required.
Claim Objections
Claim 9 objected to because of the following informalities:
In line 12 “with the advanced mounted” is assumed to be a typo. The examiner suggests amending this informality to “with the advancer mounted” and has been examined as such.
In line 15 “introducer catheter” is assumed to be a typo. The examiner suggests amending this informality to “introducer shaft” and has been examined as such.
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 10-11 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.
Regarding claim 10, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 11 is rejected due to dependency from claim 10.
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.
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 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Andreacchi et al. (US PG Pub No. 2012/0296313 A1) in view of Castelli et al. (US PG Pub No. 2020/0398026).
Regarding claim 9, Andreacchi discloses a system comprising: an introducer (see annotated Fig. 8 below), the introducer comprising an introducer hub (Figs. 2-8, hemostatic valve 240) and an introducer shaft (Figs. 2-8, guide catheter 230) extending distally from the introducer hub (see annotated Fig. 8 below); a delivery catheter (Figs. 2-8, balloon catheter 200), the delivery catheter (200) including an outer shaft (Figs. 2-8, expandable member 210); and an advancer (Figs. 1-8, introducer sheath 100), the advancer including an advancer hub (Figs. 1-8, flared portion 160) and an advancer shaft (Figs. 1-8, tubular member 110) extending distally (Figs. 1-8, distal end 170) therefrom, wherein: the advancer (100) is mounted (Figs. 3-8) over the delivery catheter (200) such that a distal portion of the outer shaft (see annotated Fig. 8 below, 210) of the delivery catheter extends through the advancer hub (160) and the advancer shaft (110); the delivery catheter (200) with the advancer mounted thereon is configured to be advanced (Figs. 2-7) through the introducer hub (240) and the introducer shaft (230) such that the advancer (100) provides axial stiffness (Paragraph [0040]) to the delivery catheter (200) as the delivery catheter is advanced through the introducer hub (240) and the introducer shaft (230); and the advancer shaft (110) and the advancer hub (160) are peelable (Paragraphs [0015 and 0048]) such that the advancer (100) is configured to be removed (Paragraph [0048], Figs. 5-7) from around the delivery catheter (200) and from within the introducer (230, 240) after a distal portion of the delivery catheter is advanced distally past a distal end of the introducer shaft (Paragraph [0048]). Andreacchi fails to disclose the delivery catheter including a handle and an outer shaft extending distally from the handle.
Castelli also discloses a system (Fig. 1), an introducer hub (Fig. 23, hub 2394), an introducer sheath (Fig. 23, introducer sheath 2395), a delivery catheter (Figs. 1 and 20-24, catheter 100), an advancer shaft (Figs. 1, 8A-8B, and 20-24, strain relief component 170), and an advancer hub (Figs. 1 and 20-24, knob 152). Castelli teaches the delivery catheter including a handle (Figs. 1 and 21, handle 112) and an outer shaft (Figs. 1 and 21, shaft 102) extending distally (Figs. 1 and 21) from the handle (112). 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 modified Andreacchi’s system wherein the delivery catheter including a handle and an outer shaft extending distally from the handle, as taught by Castelli, in order to allow for rotation of the catheter about the longitudinal axis (Paragraphs [0048 and 0052], Fig. 1, arrow 117).
PNG
media_image1.png
593
344
media_image1.png
Greyscale
Regarding claim 10, Andreacchi fails to disclose further comprising a valve relief component including a valve relief hub and a valve relief shaft, wherein the valve relief component is configured to be disposed within the introducer hub such as to protect a distal portion of the delivery catheter from a seal of the introducer hub. Castelli teaches further comprising a valve relief component (Fig. 20-24, valve relief component 2080) including a valve relief hub (Fig. 20-24, hub 2090) and a valve relief shaft (Fig. 20-24, sheath 2086), wherein the valve relief component (2080) is configured to be disposed within (Fig. 23, 2086 is within 2394) the introducer hub (Fig. 23, hub 2394) such as to protect a distal portion of the delivery catheter from a seal of the introducer hub (Paragraph [0071]). 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 modified Andreacchi’s system further comprising a valve relief component including a valve relief hub and a valve relief shaft, wherein the valve relief component is configured to be disposed within the introducer hub such as to protect a distal portion of the delivery catheter from a seal of the introducer hub, as taught by Castelli, in order to relieve strain on the distal portion of the delivery catheter (Paragraph [0050]).
Regarding claim 11, Andreacchi as modified by Castelli further discloses wherein the valve relief hub (Fig. 20-24, hub 2090) is configured to mate (Paragraph [0074], “2080 is slidable relative to the shaft 102” therefore can slide to mate with 2394) with the introducer hub (Fig. 23, hub 2394), and the valve relief shaft (2086) is configured to extend through the introducer hub (2394) but not extend through the introducer shaft (2395) (see Fig. 23).
Regarding claim 12, Andreacchi as modified by Castelli further discloses wherein the advancer hub (Figs. 1 and 20-24, knob 152) is configured to be disposed proximal (see Fig. 21) of the valve relief hub (Fig. 20-24, hub 2090) and the advancer shaft (Figs. 1 and 20-24, strain relief component 170) is configured to extend (Paragraph [0059], the ring 177 mates with 2080 which slides to mate with 2394) through the valve relief hub (2090), and the valve relief shaft (2086), but fails to disclose the advancer shaft configured to extend through the introducer shaft (2395). Instead, Andreacchi as modified by Castelli teaches the advancer shaft (ring 177 of 170) mates with the valve relief component (2080) which is slidably mated with the introducer hub (2394). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the advancer shaft (170) to further extend through the introducer shaft (2395), as doing so would have yielded predictable results, namely the advancer shaft configured to extend through the introducer shaft.
Regarding claim 13, Andreacchi in view of Castelli discloses the delivery catheter (Figs. 2-8, balloon catheter 200), but fails to disclose the delivery catheter includes a heart valve prosthesis mounted on a distal portion thereof, wherein a distal end the advancer shaft terminates proximal of the heart valve prosthesis. Castelli further discloses wherein the delivery catheter (Figs. 1 and 20-24, catheter 100) includes a heart valve prosthesis mounted on a distal portion (Figs. 1 and 21, balloon expandable prosthesis 101) thereof, wherein a distal end the advancer shaft (170) terminates proximal (see Fig. 21) of the heart valve prosthesis (101). It would have been obvious to one of ordinary skill in the art before effective filing date of the invention to include a heart valve prosthesis as taught by Castelli in the system of Andreacchi, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Regarding claim 14, Andreacchi as modified by Castelli further discloses wherein the delivery catheter is a balloon catheter (Figs. 1 and 20-24, catheter 100, balloon 105), the heart valve prosthesis (Figs. 1 and 21, balloon expandable prosthesis 101) is mounted on a balloon (Fig. 1, balloon 105) of the balloon catheter (Figs. 1 and 20-24, catheter 100).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Connors et al. (US PG Pub No. 2019/0224448 A1) also discloses a system comprising: an introducer (Fig. 1A, introducer sheath 22); a delivery catheter (Fig. 1A, catheter 16), an advancer (Fig. 1A, tubular sheath 12), and an expandable balloon (Fig. 1A, balloon 14).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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, Melanie Tyson can be reached at 5712729062. 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.
/K.L.C./ Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/ Primary Examiner, Art Unit 3700
Prosecution Insights