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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02 Jan 2026 has been entered.
Status of Claims
Claims 41-60 are currently under examination. No claim has been cancelled, added, nor withdrawn since the Final Office Action of 02 Oct 2025.
Examiner’s Comment
For a compact prosecution, Examiner proposed Examiner’s amendment (see attached Interview Summary) to place the instant application in condition for allowance. However, Applicant could not provide a response within the limited time.
Response to Amendment
Applicant is reminded that the proposed amendment to claims of 03 Nov 2025 filed after Final Office Action of 02 Oct 2025 was not entered (see the Advisory Action of 12 Nov 2025). Therefore, the claims of 02 Jan 2026, which include the proposed amendment of 03 Nov 2025, should have properly marked the proposed claim amendment of 03 Nov 2025 and the status identifiers should read “currently amended” rather than “previously presented” accordingly. See MPEP 714.II.C.
Response to Arguments
Applicant’s arguments, see pg. 7, filed 02 Jan 2026, 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 The 35 U.S.C. 112(b) rejection of 02 Oct 2025 has been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 7, filed 02 Jan 2026, with respect to the 35 U.S.C. 102 rejection to claim 60 have been fully considered and are persuasive. The 35 U.S.C. 102 rejection of 02 Oct 2025 to claim 60 is hereby withdrawn, and claim 60 is allowable. See the Reasons for Indication of Allowable Subject Matter for claim 60 below.
Applicant’s arguments, see pg. 7-11, filed 02 Jan 2026 with respect to the 35 U.S.C. 103 rejections to claims 41-59 have been fully considered and are persuasive in part.
Regarding claims 41-54, the 35 U.S.C. 103 rejections of 02 Oct 2025 are hereby withdrawn, and claims 41-54 are allowable. See the Reasons for Indication of Allowable Subject Matter for claims 41-54 below.
Regarding claims 55-59, Applicant first argues, see pg. 9, that “claim 55 recites that the first marker material is configured to expand more rapidly than the second marker material. Nothing in Ahari appears to support the position of the Office that “Ahari’s collagen and hydrogel would inherently exhibit different rates of absorption.” See Advisory Action, page 3. Further the present application includes collagen and hydrogel that may be unique for the claimed configuration”. However, the Examiner respectfully disagrees. As explained in the Advisory Action of 12 Nov 2025, neither the claim nor the original specification of the instant application defines the claimed first material (specifically collagen) and second material (specifically hydrogel) to distinguish from Ahari's collagen and hydrogel, respectively: there is no disclosure of the claimed collagen and hydrogel to be of a special composition of collagen and hydrogel, respectively. Applicant argues without any factual evidence that “the present application includes collagen and hydrogel that may be unique for the claimed configuration”: otherwise, applicant failed to disclose in the original specification the “unique” composition of “collagen and hydrogel that may be unique for the claimed configuration”, as applicant argued, at the time of filing of the instant application. Paragraphs [00076], [00085], [00094], [00097], [000106], [000114], [000121], [000128]-[000129], [000137], [000148], [000159], [000168], and [000177] of the original specification of the instant application merely disclose repeatedly that the disclosed markers are comprised of collagen (the first marker material recited in claim 55) and hydrogel (the second marker material recited in claim 55) and that the collagen is more prone to rapid absorption of moisture than the hydrogel, thus the collagen provides a rapid expansion and the hydrogel provides a slower expansion. Further, as previously explained in the Final Office Action of 02 Oct 2025 and Advisory Action and presented below, Ahari discloses in Fig. 6 its collagen outer portions 265 and hydrogel inner portion 263 arranged adjacent to each other as Fig. 5 of the instant application discloses:
Instant Application
Ahari et al. (US PG Pub No. 20170231716)
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. Therefore, while Ahari does not explicitly disclose that its collagen outer portions are configured to expand at a rapid rate relative to its hydrogel inner portion in a presence of moisture, Ahari’s collagen outer portions would inherently expand at a rapid rate relative to its hydrogel inner portion in a presence of moisture based on the original specification of the instant application. Furthermore, paragraphs [00078]-[00079] of the original specification of the instant application explicitly disclose that the difference in the expansion properties between adjacently arranged collagen and hydrogel in presence of a moisture inherently results in an irregularly shaped marker disclosed in Fig. 7, in which the expansion of the collagen outer portion at the interface directly adjacent to the hydrogel inner portion is contained, or restricted. Therefore, while Ahari does not explicitly disclose that the interfaces between its collagen outer portions and hydrogel inner portion are configured to restrict a diameter of each of its collagen outer portions near each respective interface, since Ahari’s collagen outer portions are arranged directly adjacent to hydrogel inner portion (see at least Fig. 6 above), the interfaces between Ahari’s collagen outer portions and hydrogel inner portion would inherently restrict a diameter of each of its collagen outer portions near each respective interface due to the difference in inherent expansion properties between adjacently arranged Ahari’s collagen outer portions and hydrogel inner portion. Examiner further notes that Ahari’s marker 260 in Fig. 6 is in the state for delivery to a biopsy site (see [0066] of Ahari: marker (260) used in lieu of marker (60) described above, and Fig. 3B-D and [0061]: a biopsy device or target set to deliver marker (60) at a biopsy site), not in a biopsy site delivered state. Additionally, Applicant is reminded that claims 55-59 are directed to a product, not a method. See MPEP 2112.01.I.
Applicant further argues, see pg. 9-10, that “neither Sakamoto nor Eby appear to be a comparative study of the benefits of using collagen vs hydrogel, such that there a multitude of differences between the studies. To extrapolate a vague comparison without a statistical analysis only yields conjecture.” However, the Examiner respectfully disagrees. As explained in the Advisory Action, Sakamoto and Eby were relied upon as evidence, as explicitly noted in pg. 21 of the Final Office Action, for the advantage of arranging a metallic marker within a hydrogel rather than within a collagen that would be apparent to one of ordinary skill in the art even when Sakamoto and Eby are considered independently. Sakamoto and Eby are certainly relevant evidence in the same field of a marker comprising a metallic marker element within a hydrogel or a collagen as the instant application. Sakamoto explicitly discloses that hydrogel provides “a long-term sonographic detectability” (see Abstract of Sakamoto), whereas Eby explicitly discloses that “sonographic visibility of collagen-based marker clips is variable and likely decreases over time” (see Abstract of Eby). One of ordinary skill in the art would certainly recognize in view of Sakamoto and Eby that arranging the marker element within a hydrogel for the purposes of ultrasound imaging would be advantageous rather than the marker element be arranged within a collagen (see pg. 21 of the Final Office Action). Also see MPEP 2141.III. Rationales to support rejections under 35 U.S.C. 103. Applicant again fails to provide any factual evidence that one of ordinary skill in the art would not be motivated in view of Sakamoto and Eby to modify Ahari’s marker 260 comprising metallic marker 264 within a collagen in Fig. 6 in view of Ahari’s marker 360 comprising metallic marker with central twist 366 within a hydrogel in Fig. 7. Further, Examiner again notes that a review of the original specification of the instant application does not disclose any criticality of arranging the marker element specifically within a hydrogel rather than within a collagen.
Applicant additionally argues, see pg. 10, that “In the Advisory Action, the Office alleges that Ahari element 364, annotated as “MARKER ELEMENT,” below, is an “interface between hydrogel inner core 363 and collagen outer shell 361”. However, the Examiner respectfully disagrees. In [0067], Aharai explicitly discloses that “marker element (364) of the present example may be generally rectangular with a central twist (366) so as to be configured to enhance the radiographic visibility of marker element (364)”, and the Examiner relied specifically on the central twist 366 of the metallic marker at the center of the hydrogel inner core 363 (see pg. 22 of the Final Office Action). As further presented below, Ahari clearly discloses in Fig. 7 central twist 366 of a metallic element disposed at a center portion of the hydrogel inner core 363:
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. Therefore, Applicant’s allegation that the Examiner specifically relied on marker element 364 and that “Ahari is clear that 364 is a radiopaque marker element and therefore clearly teaches away from this element being an alleged interface” are not persuasive.
Applicant lastly argues, see pg. 11, that “the Office has failed to articulate a rationale as to why a person having ordinary skill in the art would have modified the teachings of the combined art of record to include the above-noted limitation”. However, the Examiner respectfully disagrees. Examiner indeed explicitly articulated in pg. 21 of the Final Office Action “The motivation for the modification (of Ahari’s metallic marker 264 within a central collagen portion of marker 260 in Fig. 6 in view of Ahari’s central twist 366 within a central hydrogel portion of marker 360 in Fig. 7) would have been since hydrogel is well known in the art to provide “a long-term sonographic detectability”, as evidenced by Sakamoto (Abstract), compared to a collagen, whose “sonographic visibility of collagen-based marker clips is variable and likely decreases over time”, as evidenced by Eby (Abstract), and the modification of having the marker element in the hydrogel would also allow aligned detection of the marker across ultrasound and x-ray imaging modalities”, which Applicant does not appear to reasonably consider. As explained above, one of ordinary skill in the art would certainly recognize in view of Sakamoto and Eby, as evidence, that arranging the marker element within a hydrogel for the purposes of ultrasound imaging would be advantageous rather than the marker element be arranged within a collagen. See the 35 U.S.C. 103 rejections below.
Claim Objections
Claim 41 is objected to because of the following informality: “wherein each of the first portion, the second portion and the third portion are configured to expanded to” should read “wherein each of the first portion, the second portion and the third portion is configured to expand to”. Appropriate correction is required.
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 55-58 are rejected under 35 U.S.C. 103 as being unpatentable over Ahari et al. (US PG Pub No. 2017/0231716) – hereinafter referred to as Ahari – as evidenced by Sakamoto et al. (Sakamoto et al. Evaluation of the dislocation and long-term sonographic detectability of a hydrogel-based breast biopsy site marker. Breast Cancer. 25, 575–582 (2018). doi: 10.1007/s12282-018-0854-8. A copy previously provided in the Final Office Action of 02 Oct 2025.) – hereinafter referred to as Sakamoto – and Eby et al. (Eby et al. Preoperative and intraoperative sonographic visibility of collagen-based breast biopsy marker clips. Acad Radiol. 17(3):340-7 (2010). doi: 10.1016/j.acra.2009.10.017. Epub 2009 Dec 30. A copy previously provided in the Final Office Action of 02 Oct 2025.) – hereinafter referred to as Eby.
Regarding claim 55, Ahari discloses a biopsy site marker in the first embodiment (Fig. 6) comprising:
(a) a carrier (Fig. 6: resorbable body 262), the carrier including;
(i) an inner carrier portion (Fig. 6: hydrogel intermediate portions 263) defining a proximal end and a distal end (see annotated Fig. 6 below):
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,
(ii) a pair of outer carrier portions (Fig. 6: two collagen end portions 265), each outer carrier portion being disposed on the proximal end and the distal end of the inner carrier portion, respectively (see annotated Fig. 6 above),
(iii) a first interface disposed between the proximal end of the inner carrier portion and the corresponding outer carrier portion (see annotated Fig. 6 above), and
(iv) a second interface disposed between the distal end of the inner carrier portion and the corresponding outer carrier portion (see annotated Fig. 6 above); and
(b) a marker element (Fig. 6: radiopaque marker element 264),
the pair of outer carrier portions both including a first marker material (Fig. 6 and [0066]: end portions 265 of collagen),
wherein the first marker material of each outer carrier portion extend continuously from corresponding first and second interfaces to respective terminal ends of the carrier (see annotated Fig. 6 above: end portions 265 of collagen extending continuously from the annotated terminal end to the annotated first interface and from the annotated other terminal end to the annotated second interface),
the inner carrier portion including a second marker material (Fig. 6 and [0066]: intermediate portions 263 of hydrogel) extending from the proximal end to the distal end (see annotated Fig. 6 above),
wherein the marker element is disposed within a collagen intermediate portion of the inner carrier portion (Fig. 6: radiopaque marker element 264 within middle portion 261 of resorbable body 262).
Although Ahari does not explicitly disclose that its first marker material being configured to expand at a rapid rate relative to its second marker material in the presence of moisture, a review of the specification of the instant application discloses in at least [00076] that the claimed first marker material is collagen and the claimed second marker material is hydrogel, and that collagen is more prone to rapid absorption of moisture than hydrogel is. Therefore, Ahari’s collagen end portions 265 inherently expand at a rapid rate relative to Ahari’s hydrogel intermediate portions 263 in the presence of moisture.
Additionally, although Ahari does not explicitly disclose that its first and second interfaces both being configured to restrict a diameter of each outer carrier portion near the first and second interfaces, respectively, a review of the specification of the instant application discloses in [00078]-[00079] that the material difference between the outer carrier portions and the inner carrier portion near the interfaces, specifically the outer carrier portions absorbing moisture more rapidly than the inner carrier portions do near the interfaces, results in the interfaces between the outer carrier portions and the inner carrier portion restricting the diameter of each outer carrier portion near the interfaces. Therefore, the interfaces between Ahari's collagen end portions 265 and hydrogel intermediate portions 263 would inherently restrict the diameter of Ahari's collagen end portions 265, or the outer carrier portions, respectively, due to the material difference between Ahari's collagen end portions and hydrogel intermediate portions 263 near the interfaces between these portions.
Ahari does not disclose in the first embodiment:
wherein the marker element is disposed in the second marker material.
Ahari, however, in a different embodiment teaches:
a marker element (Fig. 7: central twist 366 of marker element) disposed within a hydrogel (see annotated Fig. 7 below and [0067]: central twist 366 of marker element at the center of hydrogel inner core 363):
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to rearrange the marker element of Ahari’s first embodiment, which is within a collagen middle portion of the carrier, to be within a hydrogel portion. See MPEP 2144.04.VI.C. One of ordinary skill in the art could rearrange, for example, the collagen middle portion 261 in Fig. 6 of Ahari to be of hydrogel, as shown in Fig. 7 of Ahari, and the modification would result in a reasonable success, since all embodiments of Ahari are directed to a marker comprising a collagen portion, a hydrogel portion, and a marker element within either the collagen or hydrogel portion. The motivation for the modification would have been since hydrogel is well known in the art to provide “a long-term sonographic detectability”, as evidenced by Sakamoto (Abstract), compared to a collagen, whose “sonographic visibility of collagen-based marker clips is variable and likely decreases over time”, as evidenced by Eby (Abstract), and the modification of having the marker element in the hydrogel would also allow aligned detection of the marker across ultrasound and x-ray imaging modalities.
Regarding claim 56, Ahari discloses all limitations of claim 55, as discussed above, and Ahari further discloses:
wherein the inner carrier portion includes hydrogel (Fig. 6 and [0066]: intermediate portions 263 of hydrogel),
the pair of outer carrier portions each includes hydrogel (Fig. 6 and [0066]: end portions 265 of collagen),
the inner carrier portion and the pair of outer carrier portions are arranged axially (Fig. 6: collagen end portions 265 and hydrogel intermediate portions 263 in a linear arrangement), and
the first interface and the second interface both coupling the inner carrier portion (Fig. 6: hydrogel intermediate portions 263) and one of the pair of outer carrier portions (Fig. 6: collagen end portions 265), respectively (see the annotated Fig. 6 above in claim 55).
Although Ahari does not explicitly disclose the first interface and the second interface both being configured to restrict a diameter of each outer carrier portion near the first interface and the second interface, respectively, to correspond to a diameter defined by the inner carrier portion, a review of the specification of the instant application discloses in [00078]-[00079] that the material difference between the outer carrier portions and the inner carrier portion near the interfaces, specifically the outer carrier portions absorbing moisture more rapidly than the inner carrier portions do near the interfaces, results in the interfaces restricting a diameter of each of the pair of outer carrier portions near the interfaces, respectively. Therefore, the interfaces between Ahari’s collagen end portions 265 and hydrogel intermediate portions 263 in a linear arrangement would inherently restrict the diameter of each of the collagen end portions 265 near the interfaces facing the hydrogel intermediate portions 263.
Regarding claim 57, Ahari discloses all limitations of claim 55, as discussed above, and Ahari further discloses:
wherein the inner carrier portion includes hydrogel (Fig. 6 and [0066]: intermediate portions 263 of hydrogel),
the pair of outer carrier portions each includes hydrogel (Fig. 6 and [0066]: end portions 265 of collagen),
the inner carrier portion and the pair of outer carrier portions are arranged axially (Fig. 6: collagen end portions 265 and hydrogel intermediate portions 263 in a linear arrangement), and
each outer carrier portion defining a respective outer end (Fig. 6: free ends of collagen end portions 265 not facing hydrogel intermediate portions 263).
Although Ahari does not explicitly disclose each outer end being configured to flare outwardly relative to the first interface and the second interface, respectively, in presence of moisture, a review of the specification of the instant application discloses in [00078]-[00079] that the material difference between the outer carrier portions and the inner carrier portion near the interfaces, specifically the outer carrier portions absorbing moisture more rapidly than the inner carrier portions do near the interfaces, results in each outer end of each outer carrier portion flaring outwardly relative to the first interface and the second interface, respectively, in the presence of moisture. Therefore, each outer end of Ahari’s collagen end portions 265 not facing hydrogel intermediate portions 263 would inherently flare outwardly relative to the first and second interfaces, respectively, where the collagen end portions 265 interface with hydrogel intermediate portions 263 in a linear arrangement, in the presence of moisture.
Regarding claim 58, Ahari discloses all limitations of claim 55, as discussed above, and Ahari further discloses:
the marker element (Fig. 6: radiopaque marker element 264) being disposed within the inner carrier portion (Fig. 6: inner carrier portion as two hydrogel intermediate portions 263 and collagen middle portion 261 in a cylindrical shape with radiopaque marker element 264 in the center).
Allowable Subject Matter
Claims 41-54 and 60 are allowable.
Claim 59 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
REASONS FOR INDICATION OF ALLOWABLE SUBJECT MATTER
The following is a statement of reasons for the indication of allowable subject matter:
When claims 41-54 are considered as a whole, the prior arts of record do not disclose, neither individually nor in combination, at least a marker comprising a carrier; a marker element, and a marker material interface, wherein the carrier includes a first portion, a second portion, and a third portion, the third portion being disposed between the first portion and the second portion, wherein the first portion and the second portion both include a first marker material and are separate from one another, wherein the third portion includes a second marker material, wherein the first marker material is configured to expand at a rapid rate relative to the second marker material in a presence of moisture, wherein the marker element is disposed within the third portion, wherein each of the first portion, the second portion, and the third portion are configured to expand to an expanded configuration when in the presence of moisture, wherein each of the first portion and the second portion include a larger circumference than the third portion when each of the first portion, the second portion, and the third portion are in the expanded configuration; and wherein marker material interface including a first marker material interface and a second marker material interface, wherein the first marker material interface is disposed between the first portion and the third portion, and wherein the second marker material interface is disposed between the second portion and the third portion, the marker material interface coupling the first portion and the second portion to the third portion respectively, the marker material interface being configured to locally restrict expansion of an interior side of each of the first portion and the second portion, respectively. In particular, Ahari, a prior art previously made of record, discloses a marker comprising a carrier, a marker element, and a marker material interface, wherein the marker material interface includes first and second marker material interfaces between hydrogel and collagen portions of the carrier (see pg. 9-12 of the Final Office Action of 02 Oct 2025) and further discloses in a different embodiment a marker element disposed within a hydrogel middle portion (see pg. 12 of the Final Office Action). However, Ahari et al. does not disclose at least each of the first portion, the second portion, and the third portion is configured to expand to an expanded configuration when in the presence of moisture, wherein each of the first portion and the second portion include a larger circumference than the third portion when each of the first portion, the second portion, and the third portion are in the expanded configuration. The technical advantage of the claimed invention of claims 41-54 is to provide a biopsy site marker that is capable of anchoring itself by the differential circumference and avoid “migrat(ing) from the biopsy site to another nearby location during the intervening time between the biopsy procedure and subsequent follow-up procedures” (see pg. [00004] of the specification of the instant application).
Regarding claim 59, see the Non-Final Office Action of 18 Jun 2025 for the reasons for indication of allowable subject matter for claim 59.
When claim 60 is considered as a whole, the prior arts of record do not disclose, neither individually nor in combination, at least a marker comprising: (a) a carrier defining a proximal-most end and a distal-most end, the carrier including: (i) an inner carrier portion defining a proximal end and a distal end, (ii) a proximal outer carrier portion, (iii) a distal outer carrier portion, the distal outer carrier portion and the proximal outer carrier portion being disposed on the proximal end and the distal end of the inner carrier portion, respectively, (iv) a first interface disposed between the proximal end of the inner carrier portion and the proximal outer carrier portion, and (v) a second interface disposed between the distal end of the inner carrier portion and the distal outer carrier portion; and (b) a marker element disposed within the carrier, the proximal outer carrier portion including a first marker material extending from the proximal-most end to the first interface and the distal outer carrier portion including the first marker material extending from the distal-most end to the second interface, the inner carrier portion including a second marker material extending continuously from the first interface to the second interface, the first marker material being configured to expand at a rapid rate relative to the second marker material in a presence of moisture; and the first interface and the second interface both being configured to locally restrict a size of the proximal outer carrier portion and the distal outer carrier portion near the first interface and the second interface, respectively. In particular, Ahari, a prior art previously made of record, discloses the claimed marker (see pg. 5-8 of the Final Office Action), but the inner carrier portion including the second marker material extending non-continuously from the first interface to the second interface (see the annotated Fig. 7 below: inner carrier portion comprising collagen middle portion 261 in between two hydrogel intermediate portions 263):
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It would be nonobvious to one of ordinary skill in the art to modify the inner carrier portion of Ahari’s marker 260 in annotated Fig. 6 above to be of a single hydrogel extending continuously from the first interface to the second interface. The technical advantage of the claimed invention of claim 60 is to provide a biopsy site marker that is capable of anchoring itself by the differential circumference and avoid “migrat(ing) from the biopsy site to another nearby location during the intervening time between the biopsy procedure and subsequent follow-up procedures” (see [00004] of the specification of the instant application) with the “marker element (512) remains centered within a biopsy site as marker materials (522, 524) degrade or absorb into tissue” (see [00077] of the specification of the instant application).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 01/12/26