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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 17 Jun 2026 has been entered.
Response to Arguments
Applicant’s arguments, see 6, filed 17 Jun 2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections of 24 Feb 2026 have been withdrawn in view of amended claim 16.
Applicant’s arguments, see 6-8, filed 17 Jun 2026, with respect to the 35 U.S.C. 102 and 103 rejections have been considered but 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.
Status of Claims
Claims 1-3, 6-8, and 11-20 are currently under examination. Claims 4-5 have been cancelled since the Final Office Action of 24 Feb 2026.
Claim Objections
Claim 1 is objected to because of the following informality:
“set a a pre-deployment configuration” should read “set a pre-deployment configuration”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 6-8, and 11-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the amended limitation “each arm of the plurality of arms being configured to be responsive to heat to transition or set a a pre-deployment configuration or a post-deployment configuration”. A review of the original specification, however, does not disclose each arm of the plurality of arms being configured to be responsive to heat to set a pre-deployment configuration. The original specification only discloses transitioning, or setting, from the pre-deployment configuration to the post-deployment configuration (see [00034], [00040] of the specification of the instant application). Therefore, the amended limitation introduces new matter that was not described in the original specification to reasonably convey that the inventors had possession at the time the application was filed. Claims 2-3, 6-8, and 11-15 inherit the deficiency by the nature of their dependency on claim 1.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 20 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 20 recites the limitation “the post deployment position being sent in response to heat”. The antecedent basis for “the post deployment position” is unclear. It is unclear whether “the post deployment position” is referring to “a post-deployment configuration” also recited in claim 20. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “the post-deployment configuration being sent in response to heat”.
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, 11-13, and 15-19 are rejected under 35 U.S.C. 102 as being anticipated by Hornscheidt et al. (US PG Pub No. 2019/0201160) – hereinafter referred to as Hornscheidt (‘160).
Regarding claim 1, Hornscheidt (‘160) discloses a biopsy site marker (at least Fig. 8-9), comprising:
a marker element (Fig. 8-9: marking device 100’’’’’) , the marker element including a base portion (Fig. 8-9: ends of tube 111’’’’’; [0109]: longitudinal ends of tube 111’’’’’ are not slit) and an anchor portion (Fig. 8-9: segments 113’’’’’; [0109]: slits 112’’’ separates segments 113’’’’’ to allow segments 113’’’’’ to arch outward in the relaxed, expanded state of the marking device 100’’’’’),
the anchor portion extending distally from the base portion (Fig. 8-9: segments 113’’’’’ extending distally from each ends of tube 111’’’’’), the anchor portion including a plurality of arms (Fig. 8-9: segments 113’’’’’; [0109]: segments 113’’’’’ separated from one another by slits 112’’’’’), each arm of the plurality of arms being configured to be responsive to heat to transition or set a pre-deployment configuration or a post-deployment configuration ([0033]: marking device of nitinol and configured to transform from a compressed state into a laterally expanded state),
each arm of the plurality of arms (Fig. 8: segments 113’’’’’) extending outwardly from a longitudinal axis defined by the marker element when the plurality of arms are in the post-deployment configuration (Fig. 8: arched segments 113’’’’’; [0109]: segments 113’’’’’ separated from one another by slits 112’’’’’ arch outward in the relaxed, expanded state of the marking device 100’’’’’),
the marker element defining a plurality of relief openings (Fig. 8-9: slits 112’’’’ near ends of tube 111’’’’’), each relief opening being disposed between a pair of arms of the plurality of arms, each relief opening being configured to permit movement of each arm relative to the base portion ([0109]: longitudinal ends of tube 111’’’’’ are not slit, but slits 112’’’ separates segments 113’’’’’ to allow segments 113’’’’’ to arch outward in the relaxed, expanded state of the marking device 100’’’’’),
each arm having a curved inner surface and a curved outer surface (Fig. 8-9 and [0109]: segments 113’’’ formed on tube 111’’’’’), the curved inner surface and the curved outer surface of each arm of the plurality of arms being configured to form a contiguous hollow cylindrical shape when the plurality of arms are in the pre-deployment position (Fig. 9 and [0111]: marking device 100’’’’ is made from a slit tube having segments 113’’’’’).
It is noted that while Hornscheidt (‘160) does not explicitly disclose its segments 113’’’’’ configured to be responsive to heat to transition or set from a compressed state (or a pre-deployment configuration) to a relaxed, expanded state (or a post-deployment configuration), Hornscheidt (‘160) explicitly discloses that its marking device configured to transition from a compressed state to a relaxed, expanded state is made of nitinol (or a shape memory alloy), which is well known in the art to undergo shape transition in response to heat. Also see [00035] of the specification of the instant application. Therefore, Hornscheidt (‘160)’s segments 113’’’’ of nitinol are inherently responsive to heat to transition or set from a pre-deployment configuration to a post-deployment configuration.
Regarding claim 2, Hornscheidt (‘160) discloses all limitations of claim 1, as discussed above, and Hornscheidt (‘160) 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. 9: segments 113’’’ abutting each other; [0111]: marking device 100’’’’’ is made from a slit tube having segments 113’’’’’).
Regarding claim 3, Hornscheidt (‘160) discloses all limitations of claim 1, as discussed above, and Hornscheidt (‘160) further discloses:
each arm of the plurality of arms (Fig. 8-9: segments 113’’’’’) being arranged in a circular pattern relative to the base portion ([0109]: segments 113’’’’’ separated from one another by slits 112’’’’’ arch outward in the relaxed, expanded state of the marking device 100’’’’’ and thus encompass an interior space 103’’’’’ which is approximately spherical; [0111]: marking device 100’’’’’ is made from a slit tube having segments 113’’’’’, thus segments 113’’’’’ are in a circular arrangement even in the compressed state when viewed from an end-face, similar to Fig. 8c).
Regarding claim 6, Hornscheidt (‘160) discloses all limitations of claim 1, as discussed above, and Hornscheidt (‘160) further discloses:
each arm of the plurality of arms (Fig. 8-9: segments 113’’’’’) defining a curved profile when in the post-deployment configuration (Fig. 8a-b and [0109]: segments 113’’’’’ separated from one another by slits 112’’’’’ arch outward in the relaxed, expanded state of the marking device 100’’’’’ and thus encompass an interior space 103’’’’’ which is approximately spherical), the curved profile having an initially increasing slope followed by a decreasing slope as each arm extends distally from the base portion (Fig. 8a-b: segments 113’’’’’ sloping from ends of tube 111’’’’’ towards the center of segments 113’’’’’).
Regarding claim 7, Hornscheidt (‘160) discloses all limitations of claim 1, as discussed above, and Hornscheidt (‘160) further discloses:
the marker element being configured to slidably engage a cannula (Fig. 3A-C: marking device within cannula 242; [0102]: compressed marking device contained within cannula 242) when each arm of the plurality of arms are in the pre-deployment configuration (Fig. 9).
Regarding claim 8, Hornscheidt (‘160) discloses all limitations of claim 1, as discussed above, and Hornscheidt (‘160) further discloses:
the plurality of arms including three arms (Fig. 8-9: at least three segments 113’’’’’).
Regarding claim 11, Hornscheidt (‘160) discloses all limitations of claim 1, as discussed above, and Hornscheidt (‘160) further discloses:
each arm of the plurality of arms being integral with the base portion (Fig. 8-9 and [0109]: longitudinal ends of tube 111’’’’’ are not slit, but slits 112’’’ separates segments 113’’’’’ to allow segments 113’’’’’ to arch outward in the relaxed, expanded state of the marking device 100’’’’’).
Regarding claim 12, Hornscheidt (‘160) discloses all limitations of claim 1, as discussed above, and Hornscheidt (‘160) further discloses:
the base portion having a hollow interior and an open proximal end (Fig. 8-9: ends of tube 111’’’), the open proximal end of the base portion being configured to promote tissue in-growth (Fig. 8-9 and [0111]: marking device 100’’’’ is made from a slit tube, thus the open, hollow ends of tube 111’’’ are capable of allowing tissue in-growth).
Regarding claim 13, Hornscheidt (‘160) discloses all limitations of claim 1, as discussed above, and Hornscheidt (‘160) further discloses:
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. 8-9 and [0111]: tube 111’’’’’ is textured so as to increase ultrasound visibility).
Regarding claim 15, Hornscheidt (‘160) discloses all limitations of claim 1, as discussed above, and Hornscheidt (‘160) further discloses:
the marker element being configured as a bare marker element (Fig. 8-9 and [0033]: marking device of nitinol; [0111]: marking device 100’’’’’ is made from a slit tube having segments 113’’’’’).
Regarding claim 16, Hornscheidt (‘160) discloses a biopsy site marker (at least Fig. 8-9) comprising:
(a) a base portion (Fig. 8-9: ends of tube 111’’’’’; [0109]: longitudinal ends of tube 111’’’’’ are not slit); and
(b) an anchor portion (Fig. 8-9: segments 113’’’’’) extending from the base portion ([0109]: longitudinal ends of tube 111’’’’’ are not slit, but slits 112’’’ separates segments 113’’’’’ to allow segments 113’’’’’ to arch outward in the relaxed, expanded state of the marking device 100’’’’’), the anchor portion including a plurality of outriggers ([0109]: segments 113’’’’’ separated from one another by slits 112’’’’’ arch outward in the relaxed, expanded state of the marking device 100’’’’), each outrigger having a shape set position and a compressed position (Fig. 8 vs. 9), each outrigger being splayed from each other outrigger when in the shape set position (Fig. 8 and [0109]: segments 113’’’’’ separated from one another by slits 112’’’’’ arch outward in the relaxed, expanded state of the marking device 100’’’’’), each outrigger being configured to return to the shape set position from the compressed position, the shape set position corresponding to, or being set, when the anchor portion is exposed to a predetermined temperature ([0033]: marking device of nitinol and configured to transform from a compressed state into a laterally expanded state),
(c) a plurality of relief openings (Fig. 8-9: slits 112’’’’ near ends of tube 111’’’’’), 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 (Fig. 8-9), each relief opening being configured to permit movement of each outrigger relative to the base portion ([0109]: longitudinal ends of tube 111’’’’’ are not slit, but slits 112’’’ separates segments 113’’’’’ to allow segments 113’’’’’ to arch outward in the relaxed, expanded state of the marking device 100’’’’’),
each outrigger defining a curved inner surface and a curved outer surface, the curved inner surface and the curved outer surface of each outrigger being configured to form a hollow cylindrical shape when the plurality of outriggers are in the compressed position.
It is noted that while Hornscheidt (‘160) does not explicitly disclose its segments 113’’’’’ configured to return to the shape set position, wherein the shape set position corresponding to, or being set, when the segments are exposed to a predetermined temperature, Hornscheidt (‘160) explicitly discloses that its marking device configured to transition from a compressed state to a relaxed, expanded state is made of nitinol (or a shape memory alloy), which is well known in the art to undergo shape transition in response to heat. Also see [00035] of the specification of the instant application. Therefore, Hornscheidt (‘160)’s segments 113’’’’ of nitinol are inherently configured to return to the shape set position from the compressed position, the shape set position corresponding to, or being set, when the segments are exposed to a predetermined temperature.
Regarding claim 17, Hornscheidt (‘160) discloses all limitations of claim 16, as discussed above, and Hornscheidt (‘160) further discloses:
the marker defining a bell-shape when each outrigger is in the shape set position (Fig. 8a-b: from an end of tube 111’’’’’ to a center of segments 113’’’’’ in a bell shape).
Regarding claim 18, Hornscheidt (‘160) discloses all limitations of claim 16, as discussed above, and Hornscheidt (‘160) further discloses:
the anchor portion (Fig. 8-9: segments 113’’’’’) defining a first diameter when each outrigger is in the compressed position (Fig. 9: segments 113’’’’’ in a compressed state), the anchor portion defining a second diameter when each outrigger is in the shape set position (Fig. 9: segments 113’’’’’ in a relaxed, expanded state), the second diameter being at least double the first diameter (Fig. 9 and [0032]: diameter of the marking device in its laterally compressed state is less than 1.0 mm vs. Fig. 8c and [0030]: diameter of marking device in expanded state is up to 8 mm).
Regarding claim 19, Hornscheidt (‘160) discloses all limitations of claim 16, as discussed above, and Hornscheidt (‘160) further discloses:
the anchor portion (Fig. 8-9: segments 113’’’’’) defining a first diameter when each outrigger is in the compressed position (Fig. 9: segments 113’’’’’ in a compressed state), the anchor portion defining a second diameter when each outrigger is in the shape set position (Fig. 9: segments 113’’’’’ in a relaxed, expanded state), the second diameter being at least double the first diameter (Fig. 9 and [0032]: diameter of the marking device in its laterally compressed state is less than 1.0 mm vs. Fig. 8c and [0030]: diameter of marking device in expanded state is up to 8 mm).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hornscheidt (‘160), as applied to claim 13 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 14, Hornscheidt (‘160) discloses all limitations of claim 13, as discussed above, and Hornscheidt (‘160) does not disclose:
the surface treatment including a sand blasted surface.
In the same field of marker, Hornscheidt (‘585), however, teaches:
a 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 Hornscheidt (‘160) to include Hornscheidt (‘585)’s surface treatment. The combination would have yielded a reasonable expectation of success since both Hornscheidt (‘160) and Hornscheidt (‘585) are directed to a marker. The motivation for the combination would have been since it would be easier to sand blast the surface of the marker rather than laser engraving the surface of the marker in manufacturing the echogenic marker.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hornscheidt (‘160) in view of Krebs et al. (US PG Pub No. 2010/0198276) – hereafter referred to as Krebs.
Regarding claim 20, Hornscheidt (‘160) discloses a biopsy site marker (at least Fig. 8-9) comprising:
a marker element (Fig. 8-9: marking device 100’’’’’) defining a hollow cylindrical shape ([0111]: marking device 100’’’’ is made from a slit tube) extending from a proximal end to a distal end (Fig. 8-9: proximal end being ends of tube 111’’’’’ that are not slit and distal end being center of segments 113’’’’’),
the marker element further defining a plurality of slots (Fig. 8-9: segments 113’’’’’) extending from the distal end to a base portion (Fig. 8-9: ends of tube 111’’’’’) to define a plurality of arms ([0109]: longitudinal ends of tube 111’’’’’ are not slit, but slits 112’’’ separates segments 113’’’’’),
each arm of the plurality of arms (Fig. 8-9: segments 113’’’’’) being configured to move outwardly from a longitudinal axis defined by the marker element to a post-deployment configuration (Fig. 8 and [0109]: segments 113’’’’’ separated from one another by slits 112’’’’’ arch outward in the relaxed, expanded state of the marking device 100’’’’’), the post deployment position being set in response to heat ([0033]: marking device of nitinol and configured to transform from a compressed state into a laterally expanded state),
the marker element defining a plurality of relief openings (Fig. 8-9: slits 112’’’’ near ends of tube 111’’’’’), 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 and extending through the surface of the base portion (Fig. 8-9: slits 112’’’’ near ends of tube 111’’’’’ separating segments 113’’’’’), each relief opening being configured to permit movement of each arm relative to the base portion ([0109]: longitudinal ends of tube 111’’’’’ are not slit, but slits 112’’’ separates segments 113’’’’’ to allow segments 113’’’’’ to arch outward in the relaxed, expanded state of the marking device 100’’’’’), the plurality of slots and the plurality of relief openings being configured to permit engagement of each arm with each adjacent arm in a pre-deployment configuration (Fig. 9 and [0111]: marking device 100’’’’’ in the compressed state with segments 113’’’’’ and slits 112’’’’’ aligned with tube 111’’’’’) with each arm thereby defining a distal portion of the hollow cylindrical shape of the marker element (Fig. 9 and [0111]: marking device 100’’’’’ in the compressed state with center of segments 113’’’’’ at a distal portion from ends of tube 111’’’’ that are at a proximal portion).
Hornscheidt (‘160) does not disclose:
each relief opening defining a rounded aperture opening into each slot of the plurality of slots.
In the same field of endeavor as the instant application in reducing stress concentrations between the outriggers, Krebs, 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 Hornscheidt (‘160)’s relief openings to include Krebs’s circular relief openings. The combination would have yielded a reasonable expectation of success, since both Hornscheidt (‘160) 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]), and prevent potential ripping at the relief openings.
Conclusion
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
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
06/30/26
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