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, see pg. 6, filed 07 Nov 2025, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 15 Aug 2025 have been withdrawn. However, the Examiner notes that “wherein” clauses in dependent claims typically further clarify the narrower scope of the independent claim in the dependent claims.
Applicant’s arguments, see pg. 6, filed 07 Nov 2025, with respect to the 35 U.S.C. 112(b) rejection have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of 15 Aug 2025 have been withdrawn in view of the cancelled claim 9.
Applicant's arguments, see pg. 6-8, filed 07 Nov 2025, with respect to the 35 U.S.C. 102 and 103 rejections have been fully considered but they are not persuasive in part.
Regarding at least independent claim 1 and its dependent claims, Applicant argues, see pg. 6-7, that Liu “fail(s) to teach or suggest all of the limitations recited in amended independent claim 1”. However, the Examiner respectfully disagrees in part. Amended claim 1 recites the new limitations that were previously presented in claim 10, which is now cancelled. Further, amended claim 1 merely recites that “each relief opening being disposed between a pair of arms of the plurality of arms” and the claim does not further specify the location of the relief openings. Thus, a broadest reasonable interpretation of the claimed relief openings include any openings disposed between a pair of arms of the plurality of arms and configured to permit movement of each arm relative to the base portion. Such interpretation includes a plurality openings created by opposing branches 112 of Liu et al. (US PG Pub No. 2019/0076212) transitioning to a spherical cage-like configuration in Fig. 1A from a compressed, delivery or temporary state (Fig. 1B). See at least the 35 U.S.C. 102 rejection to claim 1 below. Additionally, as noted in the 35 U.S.C. 102 rejection to claim 1 below, Applicant may consider further specifying the location of each of the plurality of relief openings in view of at least Fig. 1 of the instant application to overcome the above broadest reasonable interpretation in view of Liu.
Regarding claims 16-20, Applicant’s arguments, see pg. 7-8, are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument. See the 35 U.S.C. 103 rejections to claims 16-20 below.
Applicant’s arguments, see pg. 8, filed 07 Nov 2025, with respect to the Double Patenting rejections have been fully considered and are persuasive. The Double Patenting rejections of 15 Aug 2025 have been withdrawn in view of the amended claims.
Status of Claims
Claims 1-8 and 11-20 are currently under examination. Claims 9-10 have been cancelled since the Non-Final Office Action of 15 Aug 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 Sep 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 16-19 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.
Claim 16 recites the new limitation “each relief opening being disposed at a point between a pair of outriggers of the plurality of outriggers where the outriggers connect to the base portion, each relief opening being configured to permit movement of each outrigger relative to the base portion, each relief opening defining a circular opening with an outlet extending between the outriggers”. The antecedent basis for “the outriggers” is unclear. It is unclear whether “the outriggers” are referring to “a pair of outriggers”; “the plurality of outriggers”; specific outriggers of “the plurality of outriggers”; or otherwise. Claims 17-19 inherit the deficiency by the nature of their dependency on claim 16. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “each relief opening being disposed at a point between a pair of outriggers of the plurality of outriggers where the plurality of outriggers connect to the base portion, each relief opening being configured to permit movement of each outrigger relative to the base portion, each relief opening defining a circular opening with an outlet extending between the pair of outriggers”.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 6-8, 11, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (US PG Pub No. 2019/0076212) – hereinafter referred to as Liu.
Regarding claim 1, Liu discloses a biopsy marker (at least Fig. 1A-B), comprising:
a marker element (Fig. 1A-B: tissue cavity marker 100),
the marker element including a base portion (Fig. 1A-B: end portions 114, 116) and an anchor portion (Fig. 1A-B: branches 112),
the anchor portion extending from the base portion (Fig. 1A-B: branches 112 between end portions 114, 116),
the anchor portion including a plurality of arms (Fig. 1A-B and [0027]: branches 112),
each arm of the plurality of arms being configured to be responsive to heat to transition from a pre-deployment configuration to a post-deployment configuration (Fig. 1A, 3C and [0027]: permanent state as spherical cage-like configuration shown in Fig. 1A; [0046]-[0050]: temperature change causes transition to permanent state),
each arm of the plurality of arms extending outwardly from a longitudinal axis defined by the marker element when in the post-deployment configuration (Fig. 1A, 3C and [0027]: permanent state as the generally spherical cage-like configuration shown in Fig. 1A; [0029]),
the marker element defining a plurality of relief openings (Fig. 1A: opening between opposing branches 112 at end portions 116; [0027]: marker 100 comprising generally spherical cage-like configuration with spaced-apart branches 112), each relief opening being disposed between a pair of arms of the plurality of arms (Fig. 1A: opening between opposing branches 112 at end portions 116; [0027]: marker 100 comprising generally spherical cage-like configuration with spaced-apart branches 112), each relief opening being configured to permit movement of each arm relative to the base portion (Fig. 1A: opening between opposing branches 112 at end portions 116; [0027]: marker 100 comprising generally spherical cage-like configuration with spaced-apart branches 112).
each relief opening defining a tear-drop shape (Fig. 1A: rounded openings between opposing branches 112 at end portions 114, 116).
It is noted that a broadest reasonable interpretation has been given to “a plurality of relief openings” to include Liu’s round openings disposed between opposing pairs of branches 112 and are configured to permit movement of each branch relative to end portions 114, 116 to permanent state (Fig. 1A) from delivery or temporary state (Fig. 1B). Applicant may consider further specifying the location of each of the plurality of relief openings in view of at least Fig. 1 of the instant application to overcome the above broadest reasonable interpretation in view of Liu.
Additionally, it is noted that “tear-drop shape” recited in the claim has been given a broadest reasonable interpretation as a rounded shape, as suggested by [0030] of the specification of the instant application and as also evidenced by Clipart Library (see attached Appendix: teardrop shape including various rounded shapes such as a circle).
Regarding claim 2, Liu discloses all limitations of claim 1, as discussed above, and Liu further discloses:
each arm of the plurality of arms being configured to abut one or more adjacent arms when in the pre-deployment configuration (Fig. 1B and [0027]: marker in compressed diameter in delivery or temporary state; [0029]).
Regarding claim 3, Liu discloses all limitations of claim 1, as discussed above, and Liu further discloses:
each arm of the plurality of arms being arranged in a circular pattern relative to the base portion (Fig. 1A and [0027]: marker 100 comprising generally spherical cage-like configuration with spaced-apart branches 112).
Regarding claim 6, Liu discloses all limitations of claim 1, as discussed above, and Liu further discloses:
each arm of the plurality of arms defining a curved profile when in the post-deployment configuration (Fig. 1A and [0027]: permanent state as the generally spherical cage-like configuration shown in Fig. 1A; [0029]), the curved profile having an initially increasing slope followed by a decreasing slope as each arm extends distally from the base portion (Fig. 1A: branches 120 at end portions 114, 116 have increasing slope followed by a decreasing slope or plateau at radiopaque markers 120 at center and away from end portions 114, 116).
Regarding claim 7, Liu discloses all limitations of claim 1, as discussed above, and Liu further discloses:
the marker element being configured to slidably engage a cannula when each arm of the plurality of arms are in the pre-deployment configuration (Fig. 3A and [0042]-[0043]: tissue cavity marker 100 provided preloaded in its temporary state in distal delivery end 320 of delivery device 300).
Regarding claim 8, Liu discloses all limitations of claim 1, as discussed above, and Liu further discloses:
the plurality of arms including three arms (Fig. 1A-B: branches 112).
Regarding claim 11, Liu discloses all limitations of claim 1, as discussed above, and Liu further discloses:
each arm of the plurality of arms being integral with the base portion (Fig. 1A-B and [0027]: branches 112 coupled together by end portions 114, 116).
Regarding claim 15, Liu discloses all limitations of claim 1, as discussed above, and Liu further discloses:
the marker element being configured as a bare marker element ([0032]: marker 100 of shape-memory polymer).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 4-5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Liu, as applied to claim 1 above, and further in view of Hornscheidt (US PG Pub No. 2019/0201160) – hereinafter referred to as Hornscheidt (‘160).
Regarding claims 4-5, Liu discloses all limitations of claim 1, as discussed above, and Liu does not disclose:
each arm having a curved inner surface and a curved outer surface (claims 3-4); and
the curved inner surface and the curved outer surface of each arm of the plurality of arms being configured to form a hollow cylindrical shape when the plurality of arms are in the pre-deployment configuration (claim 4).
Hornscheidt (‘160) in the same field of marker, however, teaches:
each arm having a curved inner surface and a curved outer surface (Fig. 8: each of segments 113””’ having a curved inner surface and a curved outer surface), and
the curved inner surface and the curved outer surface of each arm of the plurality of arms being configured to form a hollow cylindrical shape (Fig. 8-9 and [0111]: marking device 100””’ is made from a slit tube 111””’ with slits 112””’ and segments 113””’) when the plurality of arms are in the pre-deployment configuration (Fig. 9 and [0111]: marking device 100””’ in compressed state with segments 113””’ not bent outward).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the marker of Liu to include Hornscheidt (‘160)’s arms of curved inner and outer surfaces. The combination would have yielded a reasonable expectation of success since both Liu and Hornscheidt (‘160) are directed to a marker. The motivation for the combination would have been to maximize “said interior space (of the marker) can be empty or filled with, for example, hydrogel, polymer foam or suture material or enclosed by a membrane or a material layer”, as taught by Hornscheidt (‘160; [0109]).
Regarding claim 12, Liu discloses all limitations of claim 1, as discussed above, and Liu does not disclose:
the base portion having a hollow interior and an open proximal end, the open proximal end of the base portion being configured to promote tissue in-growth.
Hornscheidt (‘160) in the same field of marker, however, teaches:
a base portion (Fig. 8: slit tube 111””’) having a hollow interior (Fig. 8 and [0109]: slit tube 111””’ – a tube is known in the art to have a hollow interior) and an open proximal end, (Fig. 8 and [0109]: slit tube 111””’ – a tube is known in the art to have an open end).
The limitation “the open proximal end of the base portion being configured to promote tissue in-growth” recites intended use of the open proximal end of the base portion. While Hornscheidt (’160) does not explicitly disclose its slit tube 111””” having the open proximal end to promote tissue in-growth, Hornscheidt (‘160)’s open proximal end of slit tube 111””” would be capable of promoting a tissue in-growth as the slit tube 111””” itself is hollow and open at its ends.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the marker of Liu to include Hornscheidt (‘160)’s base portion with hollow interior. The combination would have yielded a reasonable expectation of success since both Liu and Hornscheidt (‘160) are directed to a marker. The motivation for the combination would have been to promote a tissue in-growth in anchoring the marker.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Liu, as applied to claim 1 above, and further in view of Hornscheidt (US PG Pub No. 2023/0000585, a priority date of 29 Nov 2019) – hereinafter referred to as Hornscheidt (‘585).
Regarding claim 13-14, Liu discloses all limitations of claim 1, as discussed above, and Liu does not disclose:
the marker element including a surface treatment to one or more exterior surfaces of the marker element, the surface treatment being configured to increase echogenicity of the marker element (claims 13-14); and
the surface treatment including a sand blasted surface (claim 14).
Hornscheidt (‘585) in the same field of marker, however, teaches:
the marker element including a surface treatment to one or more exterior surfaces of the marker element, the surface treatment being configured to increase echogenicity of the marker element (Fig. 1 and [0099]: marking body/support structure 100; [0038]: support structure is roughened by sandblasting in order to thus increase ultrasound visibility); and
the surface treatment including a sand blasted surface ([0038]: support structure are roughened by sandblasting in order to thus increase ultrasound visibility).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the marker of Liu to include Hornscheidt (‘585)’s surface treatment. The combination would have yielded a reasonable expectation of success since both Liu and Hornscheidt (‘585) are directed to a marker. The motivation for the combination would have been to allow the marker to be visible under ultrasound imaging ([0038] of Hornscheidt (‘585)).
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Agostinelli et al. (US PG Pub No. 2019/0223975) – hereinafter referred to as Agostinelli – in view of Krebs et al. (US PG Pub No. 2010/0198276) – hereinafter referred to as Krebs.
Regarding claim 16, Agostinelli discloses biopsy site marker (Fig. 9G-I), the biopsy site marker comprising:
a base portion (Fig. 9G-I: joining section 6w); and
an anchor portion (Fig. 9G-I: lengths of magnetic marker material 6t-v, 6x-z, 6x'-6z') extending from at least one side of the base portion (Fig. 9G-I: joining section 6w; [0093]-[0095]: lengths are joined with joining section 6w),
the anchor portion including a plurality of outriggers (Fig. 9G-I: lengths of magnetic marker material 6t-v, 6x-z, 6x'-6z'),
each outrigger having a shape set position and a compressed position ([0103]-[0104]: tubes of magnetic marker material of Nitinol alloy, and upon exposed to body temperature, material performs a shape transition and reconfigures from a pre-deployed shape that fits within a narrow gauge needle to a final deployed shape as described for Fig. 9G-I),
each outrigger being splayed from each other outrigger when in the shape set position (Fig. 9G-I and [0093]-[0095]: lengths of magnetic marker material 6t-v, 6x-z, 6x'-6z' form a tripod),
each outrigger being configured to return to the shape set position from the compressed position when the anchor portion is exposed to a predetermined temperature ([0103]-[0104]: tubes of magnetic marker material of Nitinol alloy, and upon exposed to body temperature, material performs a shape transition and reconfigures from a pre-deployed shape that fits within a narrow gauge needle to a final deployed shape as described for Fig. 9G-I),
(c) a plurality of relief openings (Fig. 9G-H: openings indicated as angles 90° or θ), each relief opening being disposed at a point between a pair of outriggers of the plurality of outriggers where the outriggers connect to the base portion (Fig. 9G-H: openings indicated as angles 90° or θ connected to joining section 6w), each relief opening being configured to permit movement of each outrigger relative to the base portion ([0093]-[0094]: three lengths of magnetic marker materials 6x,6y,6z lie parallel to each other prior to deployment and then deployed to form an orthogonal or nonorthogonal tripod).
Agostinelli does not disclose:
each relief opening defining a circular opening with an outlet extending between the outriggers.
Krebs in the same field of endeavor as the instant application in reducing stress concentrations between the outriggers, however, teaches:
relief openings (Fig. 1-2: circular openings 88) each defining a circular opening with an outlet extending between a pair of outriggers (Fig. 1-2: circular openings 88 with slots 86 between arm sections 48).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the marker of Agostinelli to include Krebs’s relief openings each defining a circular opening with an outlet extending between a pair of outriggers. The combination would have yielded a reasonable expectation of success, since both Agostinelli and Krebs are directed to outriggers configured to transition between compressed vs. decompressed positions. The motivation for the combination would have been to “reduce[s] stress concentrations and facilitate[s] bending of the arm sections 48 from the retracted condition … to the extended condition”, as taught by Krebs ([0051]).
Regarding claim 17, Agostinelli in view of Krebs discloses all limitations of claim 16, as discussed above, and Agostinelli further discloses:
the marker defining a bell-shape when each outrigger is in the shape set position (Fig. 9G-I and [0093]-[0095]: lengths of magnetic marker material 6x,6y,6z in a tripod form).
It is noted that a broadest reasonable interpretation has been given to “a bell-shape” as a shape in which comprises a narrowed and closed upper portion and a wider and open lower portion, and this includes Agostinelli’s lengths of magnetic marker material 6x,6y,6z in a tripod form when in the shape set position (Fig. 9G-I).
Regarding claim 18, Agostinelli in view of Krebs discloses all limitations of claim 16, as discussed above, and Agostinelli further discloses:
the anchor portion defining a first diameter when each outrigger is in the compressed position (Fig. 12D-E and [0103]-[0104]: material performs a shape transition and reconfigures from a pre-deployed shape that fits within a narrow gauge needle to a final deployed shape as described for Fig. 9G-I),
the anchor portion defining a second diameter when each outrigger is in the shape set position ([0103]-[0104]: material performs a shape transition and reconfigures from a pre-deployed shape that fits within a narrow gauge needle to a final deployed shape as described for Fig. 9G-I),
the second diameter being at least double the first diameter (Fig. 9G-I and [0098]: angle between lengths ranging from 38 to 120 degrees).
It is noted that Agostinelli discloses the second diameter being at least double the first diameter by its lengths of magnetic marker material 6t-v, 6x-z, 6x’-6z’ in final, post-deployed shape having up to 120 degrees opening vs. in compressed, pre-deployed shape having a 0 degree opening as shown in at least Fig. 9G-I vs. Fig. 12E.
Regarding claim 19, Agostinelli in view of Krebs discloses all limitations of claim 16, as discussed above, and Agostinelli further discloses:
the anchor portion defining a first diameter when each outrigger is in the compressed position (Fig. 12D-E and [0103]-[0104]: material performs a shape transition and reconfigures from a pre-deployed shape that fits within a narrow gauge needle to a final deployed shape as described for Fig. 9G-I),
the anchor portion defining a second diameter when each outrigger is in the shape set position ([0103]-[0104]: material performs a shape transition and reconfigures from a pre-deployed shape that fits within a narrow gauge needle to a final deployed shape as described for Fig. 9G-I),
the second diameter being at least triple the first diameter (Fig. 9G-I and [0098]: angle between lengths ranging from 90 to 120 degrees).
It is noted that Agostinelli discloses the second diameter being at least triple the first diameter by its lengths of magnetic marker material 6t-v, 6x-z, 6x’-6z’ in final, post-deployed shape having 90 to 120 degrees opening vs. in compressed, pre-deployed shape having a 0 degree opening as shown in at least Fig. 9G-I vs. Fig. 12E.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Krebs.
Regarding claim 20, Liu discloses a biopsy marker (at least Fig. 1A-B), comprising:
a marker element (Fig. 1A-B: tissue cavity marker 100),
the marker element defining a hollow cylindrical shape (Fig. 1-B and [0037]: marker comprising a tube that is hollow) from a proximal end to a distal end (Fig. 1A-B: end portions 114, 116),
the marker element further defining a plurality of slots (Fig. 1A-B: openings between branches 112 in between end portions 114, 116) extending from the distal end to a base portion (Fig. 1A-B: end portions 114, 116) to define a plurality of arms (Fig. 1A-B and [0027]: arms 112 spaced apart in generally spherical cage-like configuration at permanent state),
each of the plurality of arms being configured to move outwardly from a longitudinal axis defined by the marker element in response to heat at a biopsy site (Fig. 1A, 3C and [0027]: permanent state as spherical cage-like configuration shown in Fig. 1A; [0046]-[0050]: temperature change causes transition to permanent state),
the marker element defining a plurality of relief openings (Fig. 1A: openings between adjacent branches 112 at end portions 114, 116), each relief opening being disposed between a pair of arms of the plurality of arms at the proximal end of each slot of the plurality of slots (Fig. 1A: each opening between adjacent branches 112 at end portions 114, 116) and extending through the surface of the base portion (Fig. 1A-B: branches 112 extending to and coupled at end portions 114, 116), each relief opening being configured to permit movement of each arm relative to the base portion (Fig. 1A-B and [0026]-[0027]: branches 112 open farther apart from each other at end portions 114, 116 in deployed or permanent state than in delivery or temporary state).
Liu does not disclose:
each relief opening defining a rounded aperture opening into each slot of the plurality of slots.
Krebs in the same field of endeavor as the instant application in reducing stress concentrations between the outriggers, however, teaches:
relief openings (Fig. 1-2: circular openings 88) each defining a rounded aperture opening into each slot of the plurality of slots (Fig. 1-2: circular openings 88 with slots 86 between arm sections 48).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the marker of Liu to include Krebs’s relief openings each defining a circular opening with an outlet extending between a pair of arms. The combination would have yielded a reasonable expectation of success, since both Liu and Krebs are directed to arms configured to transition between compressed vs. decompressed positions. The motivation for the combination would have been to “reduce[s] stress concentrations and facilitate[s] bending of the arm sections 48 from the retracted condition … to the extended condition”, as taught by Krebs ([0051]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et al. (CN114469469A, a copy of machine translation relied upon attached to this Office action) discloses a relief opening that is in a teardrop shape (at least Fig. 22-23: second arc portion 214a and [174]).
Rudakov et al. (US PG Pub No. 2014/0371778) discloses a marker comprising a plurality of arms and a base portion, and the plurality of arms are configured to transition from a compressed state to a decompressed state (see at least Fig. 29A-D).
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 Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
02/20/26