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 Arguments
Applicant's arguments filed 12/08/2025 in regards to the rejection of claims 1, 5-7, and 11-13 under 35 USC 102 as being anticipated by Baldwin have been fully considered but they are not persuasive.
On pages 6-7 of the Remarks, Applicant traverses the rejection of claims 1, 5-7, and 11-13 under 35 USC 102 as being anticipated by Baldwin. Specifically, Applicant argues that Baldwin does not teach the following limitations of the amended independent claims:
The indicator surface comprising at least one marking;
A guidance projector connected to the indicator surface, the guidance projector adapted to project one or more lasers comprising at least a reference; and
A sensor adapted to detect an alignment of the reference and the at least one marking.
Examiner respectfully disagrees and again points to pages 6-7 of the Remarks where Applicant states that Baldwin discloses a guidance indicator having a first and second marking oriented perpendicular to one another to create crosshatch 42 (see Baldwin Fig. 4, [0078]). Examiner also points to paragraph [0084] where Baldwin explicitly states the cap 101 of the indicator pictured in Fig. 9 can optionally include a concentric circle pattern similar to the pattern described in connection with Fig. 4 to facilitate the positioning of the laser. Applicant and Examiner therefore agree that Baldwin discloses the first amended limitation.
Regarding the amended limitation of a guidance projector connected to the indicator surface, the guidance projector adapted to project one or more lasers comprising at least a reference, Examiner would first like to note that under the broadest reasonable interpretation of the claim language, the ‘connection’ of the guidance projector is not limited to a physical connection and the limitation may also be met by the guidance projector being optically connected to the indicator surface. Examiner then points to paragraphs [0058-0059] and [0082], which describe a laser beam 206 and/or light 114 which are projected toward the indicator surface to provide a reference which facilitates the alignment of the needle/probe assembly.
Regarding a sensor adapted to detect an alignment of the reference and the at least one marking, Examiner points to paragraph [0087], where Baldwin teaches the indicator comprising a reflective surface 111 or 112 positioned in the main housing that with a light enhancement feature can propagate light 116 to signal when there is proper alignment between the light source and the guidance indicator having at least one marking.
With this in consideration, Examiner asserts that the prior art of Baldwin teaches all of the limitations of the amended independent claim and therefore the rejection under 35 USC 102 is maintained.
Applicant’s arguments filed 12/08/2025, with respect to the rejection(s) of claim(s) 1-4 and 8-9 under 35 USC 102 as being anticipated by Zarins have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration as necessitated by the amendments to the independent claim, a new ground(s) of rejection is made under 35 USC 103 in view of Baldwin and Vidali et al (WO 2022115214 A1).
Election/Restrictions
Claims 14-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/05/2025.
Applicant's election with traverse of Group I in the reply filed on 09/05/2025 was acknowledged and deemed proper by the Examiner in the Non-Final Office Action mailed 09/23/2025.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 02/02/2023, 07/15/2024, and 09/05/2025 have been considered by the Examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5-7, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baldwin (US 20140357986 A1).
Regarding claim 1, Baldwin teaches a guidance indicator (see [0084], Fig. 9A having a guidance indicator comprising cap 101) comprising:
an indicator platform (101) having an indicator surface (see Fig. 9A; guidance cap 101 having a flat top surface);
the indicator surface comprising at least one marking (see Baldwin Fig. 4, [0078], [0084]; the cap 101 can optionally include a concentric circle pattern similar to the pattern described in connection with Fig. 4 to facilitate the positioning of the laser) and
a mounting portion connected to the indicator platform and supporting the indicator surface in a predetermined orientation relative to a needle of an ablation probe (see annotated Fig. 14A below),
the mounting portion adapted to removably attach to a complimentary attachment post of the ablation probe (see Fig. 14A wherein mounting portion of guidance cap 101 is pictured separated from the complimentary attachment post of the probe);
a guidance projector (see [0058-0059]; laser guide 204 projects laser beam 206, [0082]; a laser can facilitate insertion and removal of the needle assembly 100) connected to the indicator surface (see [0084]; laser or other light source can be shined through opening 110 of cap 101), the guidance projector adapted to project one or more lasers comprising at least a reference (see [0084]; laser can shine through the opening 110 in cap 101 to facilitate alignment); and
a sensor adapted to detect an alignment of the reference and the at least one marking (see [0087]; when light 114 and the assembly 100 are properly aligned, reflective surface 111/reflective dome 112 and/or the light enhancement feature can propagate light 116 to indicate alignment).
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Baldwin is silent regarding wherein the needle and attachment post are that of an ablation probe. However, this limitation has been identified as intended use as it is not considered to impart any further structural limitation over the prior art. Since Baldwin teaches a guidance indicator which interfaces with a probe comprising a needle, the device is capable of use where the probe is that of an ablation probe.
Regarding claim 5, Baldwin teaches the guidance indicator of claim 1. Baldwin further teaches wherein the mounting portion is connected at a center of the indicator platform opposite to the indicator surface. See annotated Fig. 14A below.
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Regarding claim 6, Baldwin teaches the guidance indicator of claim 1. Baldwin further teaches wherein the at least one marking comprises a first marking and a second marking,
the second marking oriented perpendicular to the first marking (see Fig. 4, [0078, [0084]; guidance indicator having a first and second marking oriented perpendicular to one another to create crosshatch 42).
Regarding claim 7, Baldwin teaches the guidance indicator of claim 1. Baldwin further teaches wherein the predetermined orientation comprises an orientation of the indicator surface that is substantially perpendicular to an axis of the needle. See Fig. 9 in which the surface of guidance cap 101 is perpendicular to the orientation of cannula 104 housing needle 105.
Regarding claim 11, Baldwin teaches the guidance indicator of claim 1. Baldwin further teaches wherein the mounting portion comprises one or more guide ribs positioned proximate a coupling ring, the guide ribs angled toward a center of the coupling ring to guide the attachment post into the coupling ring during assembly of the guidance indicator to the ablation probe. See annotated Fig. 14A below.
It can be appreciated that under the broadest reasonable interpretation of the claim limitations, the threading inside of cap 101 is relied upon to teach the ‘ribs’ of the claim, and the slope of said threading is regarded as ‘angled toward the center of the coupling ring’ by virtue of the motion of the cap around the center of the ring as the threaded cap mates with the probe attachment post.
The limitation of the claimed device ‘to guide the attachment post into the coupling ring during assembly of the guidance indicator to the ablation probe’ has been identified as intended use as it is not considered to impart any further structural limitation over the prior art. Since Baldwin teaches a guidance indicator having a coupling ring that may guide an attachment post into the coupling ring during assembly of the guidance indicator to a probe, the device is capable of use where the probe is that of an ablation probe.
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Regarding claim 12, Baldwin teaches the guidance indicator of claim 1, wherein the mounting portion comprises a retention cup (see Fig. 14A; threaded portion of cap 101 is regarded as retention cup) and a center of the retention cup is aligned with an axis of the needle when positioned on the ablation probe (see Fig. 14A; center of cap 101 is in axial alignment with the axis of the needle as the two axes are aligned in parallel).
Regarding claim 13, Baldwin teaches the guidance indicator of claim 1, further comprising a handle connected to the indicator platform on a side opposite to the indicator surface. It can be appreciated that the outer surface of cap 101 as seen in Baldwin Fig. 14A acts as a handle, being a surface by which to hold the device, located on a side opposite the indicator surface.
Regarding claim 21, Baldwin teaches the guidance indicator of claim 1 comprising at least one alignment notification adapted to provide a notification of the alignment (see [0087]; when the assembly 100 is aligned with the light source 114, the light enhancement feature can propagate light 116 such that there is clear visual indication of proper alignment).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-4 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Baldwin (US 20140357986 A1) in view of Vadali et al (WO 2022115214 A1). For citation purposes, Examiner will be referencing the corresponding US application Vadali et al US 20240016542 A1.
Regarding claim 2, Baldwin teaches the guidance indicator of claim 1. Baldwin further teaches wherein the mounting portion comprises a retention cup to removably couple the guidance indicator to the attachment post (see Baldwin [0086]; the cap 101 can removably engage with the main body 102). See annotated Fig. 14A below.
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Baldwin teaches alternative ways that the guidance indicator 101 can be coupled to the attachment post 102, including a threaded connection as seen in Fig. 14A or a snap fit configuration (Baldwin [0086]). Baldwin is silent regarding wherein the retention cup of the mounting portion includes a magnet.
Vadali teaches an instrument connector using magnets to operably connect an instrument to its housing. The mounting portion (100) has a retention cup (see annotated Valdali Fig. 1 below) that includes a magnet for removeable coupling (see Vadali Figs. 2-3, [0034]; magnets 105a and 105b couple the connector 100 to the instrument base 200).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the threaded coupling mechanism of the guidance indicator of Balwdin with magnetic coupling as taught by Vadali. One of ordinary skill in the art would have been motivated to make this modification in order to ensure proper alignment of the two components (Vadali, abstract) without having to ensure that a threaded connection is precisely lined up/tightened.
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Regarding claim 3, Baldwin and Vadali teach the guidance indicator of claim 2. Baldwin is silent regarding wherein the magnet is configured to removably couple to a complementary magnet in the attachment post.
Vadali teaches wherein the magnet (105a/105b) is configured to removably couple to a complementary magnet (205a/205b) in the attachment post (see Vadali [0035]; each of the magnets 105a and 105b are positioned to align with one of magnet 205a and 205b in the instrument connector when attached).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the threaded coupling mechanism of the guidance indicator of Balwdin with magnetic coupling as taught by Vadali. One of ordinary skill in the art would have been motivated to make this modification in order to ensure proper alignment of the two components (Vadali, abstract) without having to ensure that a threaded connection is precisely lined up/tightened. It would be obvious to one of ordinary skill in the art that in order to have a secure magnetic coupling of this kind, the magnets on the retention cup must have corresponding magnets on the attachment post.
Regarding claim 4, Baldwin and Vadali teach the guidance indicator of claim 2. Baldwin is silent regarding wherein the retention cup defines a cavity to receive the attachment post.
Vadali teaches wherein the retention cup defines a cavity to receive the attachment post. See annotated Vadali Fig. 1 below.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the threaded coupling mechanism of the guidance indicator of Balwdin with magnetic coupling as taught by Vadali. One of ordinary skill in the art would have been motivated to make this modification in order to ensure proper alignment of the two components (Vadali, abstract) without having to ensure that a threaded connection is precisely lined up/tightened.
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Regarding claims 8 and 9, Baldwin teaches the guidance indicator of claim 1. Baldwin is silent regarding wherein the mounting portion comprises a magnet positioned at a base of a retention cup to removably engage to the attachment post of the ablation probe; and
wherein the retention cup includes a wall, the wall and the base defining a cavity of the retention cup.
Vadali teaches wherein the mounting portion comprises a magnet (105a/105b) positioned at a base of a retention cup (see Vadali Figs. 2-3; magnets 105a/105b at the base of retention cup 100) to removably engage to the attachment post (200); and
wherein the retention cup includes a wall, the wall and the base defining a cavity of the retention cup (see annotated Vadali Fig. 1 below).
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It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the threaded coupling mechanism of the guidance indicator of Balwdin with magnetic coupling as taught by Vadali. One of ordinary skill in the art would have been motivated to make this modification in order to ensure proper alignment of the two components (Vadali, abstract) without having to ensure that a threaded connection is precisely lined up/tightened. Positioning the magnets at the base of the retention cup would also serve to ensure a complete fit rather than a partial fit of the attachment post within the retention cup.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Baldwin (US 20140357986 A1) in view of Piferi et al (US 20150031982 A1).
Regarding claim 10, Baldwin teaches the guidance indicator of claim 1. Baldwin teaches alternative ways that the guidance indicator 101 can be coupled to the attachment post 102, including a threaded connection as seen in Fig. 14A or a snap fit configuration (Baldwin [0086]). Baldwin is silent regarding wherein the mounting portion is configured to removably attach to the attachment post via an interference fit.
Piferi teaches -----------a trajectory frame to provide guidance for the deployment of probes into an area of interest (Piferi, Abstract) wherein the mounting portion is configured to removably attach to the attachment post via an interference fit (see Piferi [0161]; the cap 1132 of catheter guide 1130 may be attached to the attachment post 1102a via an interference fit).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Baldwin’s guidance indicator with an interference fit as taught by Piferi. One of ordinary skill in the art would have been motivated to make this modification in order to attach the guidance indicator to the attachment post using frictional engagement that allows for quick removal of the indicator (Piferi [0161]).
Conclusion
THIS ACTION IS MADE FINAL. 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 ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792