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 .
Response to Amendment
The examiner acknowledges the reply filed on 01/09/2026 in which claims 12 and 15 were amended. Claims 1-11 are previously withdrawn. Claims 9 and 20 have been cancelled. New claim 21 has been added. Currently, claims 12-19 and 21 are pending for examination in this application.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 10/14/2025, has been considered by the examiner.
Response to Arguments
Applicant's arguments, filed 01/09/2026, have been fully considered but they are not persuasive. Applicant’s representative asserts that the prior art of record does not disclose the invention as claimed.
The newly filed amendments to the independent claim language result in a change in scope of the claims, allowing for a change in interpretation of the previously presented prior art. However, the examiner will respond to arguments presented by applicant’s representative which are still relevant to the rejection presented below.
With regards to the prior art, applicant’s representative asserts Gough fails to teach “a plurality of secondary sensor probes, each comprising: a second length shorter than the first length, the second length extending outwardly from the main sensor probe at an angle in an unconstrained state to define a single preformed shape configured to apply a lateral force that acts as an anchoring force against tissue when deployed in a coronary sinus.” The examiner respectfully disagrees. First, the examiner would note that the claimed “first length” and “second length” are not defined, other than that the second length is shorter than the first length. In this light, the “first length” and the “second length” are arbitrary and are not required to be the full length of the main sensor probe and the plurality of the secondary sensor probes, respectively. As such, there will always be a “second length” on the secondary sensor probes which is shorter than a “first length” on the main sensor probe. Expanding on the arbitrary claimed lengths, even the very tip of the secondary sensor probe could be viewed as the “second length.”
In addition, applicant’s representative correctly states that the secondary sensors probes taught by Gough are extendable and retractable relative to the main axis of the main sensor probe. The examiner would note that claimed terms such as “unconstrained state” and “preformed shape” are not explicitly defined within the claim, nor do the terms have an explicit definition within applicant’s specification. Additionally, not only do the claims lack a definition of where/how these “lengths” are located on the respective probes, but there is further no limitation on when the claimed “state” and “shape” must occur (i.e. initial extension, mid-extension, full extension, etc.). As such, as mentioned above, even the very tip of the secondary sensory probe could be viewed as the “second length” which meets the limitation of “an unconstrained state to define a single preformed shape configured to apply a lateral force that acts as an anchoring force against tissue when deployed in a coronary sinus.” Furthermore, given that the secondary sensory probes taught by Gough are extendable relative to the main axis of the main sensor probe, they are functionally capable of applying a lateral force against another structure. In this light, applicant’s representative’s arguments are unconvincing.
In light of the remarks and standing rejection above, the examiner asserts the prior art of record teaches all elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
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.
Claims 12-19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gough et al. (USPN 5,735,847).
[Claim 12] Gough teaches an end effector (figures 1-8, item 10) for a stabilized coronary sinus catheter, the end effector comprising:
a main sensor probe (figure 1, item 14) comprising a plurality of main sensors (figure 1, item 24 located on item 14; excluding most distal sensor 24) disposed along a first length (figure 1; lacking any additional limitations, the examiner notes this is an arbitrary length) of the main sensor probe (figure 1, item 14) (column 6, lines 23-27); and
a plurality of secondary sensor probes (figure 1, item 16), each comprising:
a second length shorter than the first length (the examiner notes the “second length” is merely defined as shorter than the “first length,” as such, any portion of item 16, which is shorter than the “first length”, meets this limitation), the second length extending outwardly from the main sensor probe (figure 1, item 14) at an angle in an unconstrained state to define a single preformed shape (the examiner notes that any exposed portion of item 16 is “in an unconstrained state to define a preformed shape”) configured to apply a lateral force that acts as an anchoring force against tissue when deployed in a coronary sinus (as best shown in figure 8; Gough teaches item 16 is laterally deployable; as such, the structure is fully capable of meeting the functional limitation of applying a lateral force) ; and
a secondary sensor (item 24, as best shown on item 16 in figure 3) disposed on a distal end of the second length (column 6, lines 23-27).
[Claim 13] Gough teaches the limitations of claim 12, upon which claim 13 depends. In addition, Gough discloses the plurality of secondary sensor probes (figure 1, item 16) configured to bend inwardly toward the main sensor probe (figure 1, item 14) when inserted into a sheath (as best shown in figure 5; column 9, lines 1-5).
[Claim 14] Gough teaches the limitations of claim 12, upon which claim 14 depends. Gough also teaches the second length comprising a plurality of sub lengths (lacking any further limitations, a “sub length” is arbitrary; as such, the second length could have an infinite number of “sub lengths”), and a portion of the plurality of secondary sensor probes (figure 1, item 16) each have a different sub length (again, as the “sub length” is arbitrary, each sensor probe 16 could have “sub lengths” of different sizes).
[Claim 15] Gough teaches the limitations of claim 12, upon which claim 15 depends. Gough further teaches a midline axis (see annotated figure below),
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the main sensor probe (figure 1, item 14) is disposed approximately along the midline axis (see annotated figure above); and
the plurality of secondary sensor probes (figure 1, item 16) are approximately parallel to the midline axis (see annotated figure above) in a sheathed position (figure 2c) and form an angle away from the midline axis (see annotated figure below) in an unsheathed position corresponding to the unconstrained state (see annotated figure below).
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[Claim 16] Gough teaches the limitations of claim 15, upon which claim 16 depends. Gough also discloses a secondary sensor probe angle formed between a secondary sensor probe (figure 1, item 16) and the midline axis (see annotated figure above).
[Claims 17 and 18] Gough teaches the limitations of claims 12 and 16, upon which claims 17 and 18 depend. In addition, Gough teaches the secondary sensor probe angle between approximately 0° (“can be deflected a few degrees from the longitudinal axis”) and approximately 10° (column 7, lines 11-23; the examiner notes that the prior art need only teach a singular angle to meet the limitations of claims 17 and 18; the examiner further notes this angle could be met at any point during deployment and/or retraction).
[Claim 19] Gough teaches the limitations of claim 12, upon which claim 19 depends. Gough further discloses the plurality of main sensors (figure 1, item 24) configured to detect electrophysiological signals (column 6, lines 34-44).
[Claim 21] Gough teaches the limitations of claim 12, upon which claim 21 depends. Gough also teaches the main sensor probe (figure 1, item 14) further comprising a distal tip (figure 3, item 14’) distal to the plurality of main sensors (figure 1, item 24 located on item 14; excluding most distal sensor 24) and a single axis location sensor (figure 3, most distal sensor 24 located on 14’) (sensor 24 allows for determining “the boundary or periphery of the ablated mass”) disposed approximately at the distal tip (figure 3, item 14’) (column 6, lines 23-33).
Conclusion
Applicant's amendment necessitated the 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 JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 08/11/2026
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