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 Species B (claims 17-24) in the reply filed on 10/22/25 is acknowledged.
Claim Objections
Claim 29 is objected to because of the following informalities: “tubes” should be --tube--. 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.
Claim 31 is 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 27 recites the limitation "the valve seat". There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the system of any example, particularly examples 75-80". There is insufficient antecedent basis for this limitation in the claim. For examination purposes, claim 31 is treated as depending from claim 25.
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.
Claims 17, 21-25, 28-31 are rejected under 35 U.S.C. 103 as being obvious over Armer et al. 2017/0231756 in view of Manash et al. 2018/0263764.
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Noting figures 49A and 49B supra and regarding claims 17, 21, and 25, Armer et al. discloses a system comprising: a delivery catheter assembly comprising: an outer tube (4910) having a distal end and
a connecting tube (64); a docking station frame (10) disposed in the outer tube and coupled to the connecting tube; wherein the docking station frame is deployed by retracting the outer tube proximally relative to the connecting tube (see [0235]). With further respect to claim 25, Armer et al. further disclose an elongated nosecone (28) and docking station connector (4914), wherein the docking station frame (10) is coupled to the docking station connector (see Fig. 49B).
However, Armer et al. does not disclose one or more radiopaque markers disposed at or near the distal end of the catheter; a connecting tube having one or more radiopaque markers disposed in the outer tube.
Manash et al. teaches systems and mechanisms for deploying a docking device with a catheter for a replacement heart valve and teaches that delivery catheters and docking devices can include one or more radiopaque markers. It would have been obvious to one having ordinary skill in the art to modify the invention of Armer et al. and provide radiopaque markers on various portions of the delivery device and docking station in order to aid in delivery and proper positioning within the heart (see [0104-0105] for motivation).
The claims contain intended use recitation language as recited in claim 17, 22-25, and 28-31 for example recite:
“wherein a position of one or more radiopaque markers of the connecting tube relative to the one or more radiopaque markers of the outer tube indicate an amount of deployment of the docking station from the outer tube.” (claim 17)
“wherein the alignment of one or more of the radiopaque markers of the outer tube and one or more of the radiopaque markers of the connecting tube indicates an amount of deployment of the frame.” (claims 22 and 29)
“wherein the alignment of one or more of the radiopaque markers of the outer tube and one or more of the radiopaque markers of the connecting tube indicates a point of release for the frame.” (claims 23 and 30)
“wherein the frame is configured to be recaptured by the outer tube at any point before one of the radiopaque markers of the outer tube moves proximally past one of the radiopaque markers of the connecting tube.” (claims 24 and 31)
“wherein the one or more radiopaque markers of the outer tube, the radiopaque markers of the connecting tube, and the one or more radiopaque markers of the docking station frame are configured to visually determine correct placement of the docking station frame and a final point at which the docking station frame is recapturable by the outer tube.” (claim 25)
“wherein alignment of one of the radiopaque markers of the outer tube and the radiopaque markers of the frame indicates an amount of deployment of the frame.” (claim 28)
These limitations carry limited weight in the absence of any distinguishing structure. Amer in view of Manash et al. discloses the structure as discussed supra and the combination of the structures are thus capable of performing the functions. See MPEP 2114 which states:
II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was "for mixing flowing developer material" and the body of the claim recited "means for mixing ..., said mixing means being stationary and completely submerged in the developer material." The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.).
Allowable Subject Matter
Claims 18-20 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 27 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: A delivery catheter system as recited in claims 17 and 25 in combination with (a) one or more radiopaque markers of the outer tube is a radiopaque band embedded in the outer tube; or (b) wherein the frame includes a plurality of radiopaque markers disposed around a valve seat is novel over prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 November 5, 2025