DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Acknowledgments
This office action is in response to the preliminary amendment filed on 11/8/24. Claims 26-46 are pending.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 9/2/25 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
Claim Rejections - 35 USC § 103
4. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
5. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
6. Claims 26-46 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Legaspi et al. (US 2009/0287187) (“Legaspi”).
Legaspi discloses:
A kit for accessing a subvalvular space of a heart comprising: one or more first guide catheters, the one or more first guide catheters comprising an elongate member, a distal end, and a lumen therethrough, the distal end having a deformable portion comprising a plurality of segments having different durometers along a length thereof; and a catheter comprising a deflectable wire. [0074-0075]
further comprising one or more diagnostic catheters, the one or more diagnostic catheters comprising a preformed arch curve region and a preformed valve curve region. ([0074-0075], “any of a variety of catheters and intralumenal instruments may be configured with one or more deformation zones” …”used for other therapeutic and diagnostic procedures, including but not limited to access…”; in [0074] embodiments of various devices usable with embodiments of the invention of Legaspi are described—see particularly 11/583,627 incorporated by reference (US Pat 8,388,680 to Starksen). In this patent “any of the catheters described may be pre-shaped or pre-formed C3L6-12,C8L33-47)
claims 27-30,35-38: Given the above passages regarding the pre-formed curves and configurations with deformation zones, it is within the skill of one of ordinary skill in the art to use catheters with preforms according to claims 27-30,35-38 as a matter of obvious design choice. the preformed arch curve region corresponds to a curve of an aortic arch.
a length of each of the plurality of segments is the same; a length of each of the plurality of segments is about 2.0 mm. [0059] (actual length is a design choice that would be measurable based on the pre-form desired shape)
a first segment of the plurality segments has a Shore D durometer of 40; a second segment of the plurality of segments has a Shore D durometer of 55. [0045,0053]
the one or more diagnostic catheters is configured to inject a radiopaque contrast agent into the subvalvular space. [0075] (see Starksen C12L37-47
the one or more diagnostic catheters comprises an ultrasonic transducer. [0075]
further comprising a second guide catheter 120 (tunnel catheter 410 as in Figs. 4A-I, Starksen) comprising a lumen and a curved distal portion, the second guide catheter configured for advancement through the lumen of the one or more first guide catheters and positioning in the subvalvular space of a mitral valve and around at least a portion of a circumference of a left ventricle. [0074]
further comprising a tunnel catheter configured for advancement through the first guide catheter lumen, the tunnel catheter comprising at least one opening to facilitate deployment of an anchor 122,(426 Starksen) into tissue of the left ventricle.
the anchor is coupled to a tether [0074] (422 Starksen)
further comprising one or more termination devices; a locking device, a cutting device, or a combination locking and cutting device. See Starksen C2L40-47
further comprising a guidewire 118
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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