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 .
This Office action is responsive to an amendment filed December 22, 2025. Claims 1-11, 14-16 & 20 are pending. Claims 12-13 & 17-19 have been canceled. Claims 1, 4, 14-16 & 20 have been amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 24, 2025 and July 28, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 16 & 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levinson (US 2005/0277958).
In regards to claim 16, Levinson discloses a biopsy site marker, the biopsy site marker comprising a marker element 10 having a resilient portion (e.g., the clip 10 is made from radiopaque and reversibly compressible metals such as stainless steel or titanium, see par 0039, to a size smaller than 2-3 mm, see par 0076, so as to be visible under fluoroscopy), the marker element 10 having a first arm 12 and a second arm 14 that together form a V-shaped pattern, the marker element 10 further including one or more anchors (30, 32) extending from the distal ends of the first arm 12 and the second arm 14,
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the marker element 10 further having a resilient portion being capable of transitioning the marker element 10 between a pre-deployment state (e.g., opened) (e.g., opened) and a deployment state (e.g., opened) by flexing the first arm 12 and the second arm 14 outwardly such that the biopsy site marker transitions from a compressed state to an expanded state, the marker element 10 being capable of gripping tissue when in the deployment state (e.g., opened) (see at least fig. 3A and par 0008, 0041-0043 & 0049).
In regards to claim 20, Levinson discloses a biopsy site marker, comprising:
a marker element 10, the marker element 10 including a resilient portion (e.g., the clip 10 is made from radiopaque and reversibly compressible metals such as stainless steel or titanium, see par 0039, to a size smaller than 2-3 mm, see par 0076, so as to be visible under fluoroscopy) and a first arm 12 and a second arm 14 extending outwardly from the resilient portion,
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the resilient portion being capable of transitioning the first arm 12 and the second arm 14 from a pre-deployment state (e.g., opened) to a deployment state (e.g., opened), the marker element 10 further including one or more anchors (30, 32) extending from the distal ends of the first arm 12 and the second arm 14, the one or more anchors (30, 32) being capable of engaging tissue of a biopsy site when the biopsy site marker is in the deployment state (e.g., opened) (see at least fig. 3A and par 0008, 0041-0043 & 0049).
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 1-3 & 5-11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Selis (US 2005/0277871) in view of Levinson (US 2005/0277958).
In regards to claim 1, Selis discloses a biopsy site marker, comprising:
a marker element 22, the marker element 22 including a first portion and a second portion (e.g., first portion connected to a second portion at an apex, see at least figs. 6A-B & 6E and par 0037), the first portion and the second portion each being configured to be displaced outwardly when deployed to a biopsy site such that the biopsy site marker transitions from a compressed state to an expanded state (see at least par 0037), the marker element 22 being configured to engage tissue of the biopsy site when the biopsy site marker is in the expanded state (see at least par 0024); and
a carrier 26, the carrier 26 configured such that the marker element 22 is positioned within the carrier 26 (see at least figs. 6A-B & 6E and par 0027, 0039-0050), the carrier 26 including one or more marker materials (see at least par 0046), the carrier 26 further including a first marker material (e.g., collagen) configured to degrade over time in the presence of moisture (see at least par 0040, 0042-0043, 0046 & 0050).
Selis discloses a marker, as described above, that fails to explicitly teach a marker with the marker element further including one or more anchors extending from the distal ends of the first portion and the second portion, the one or more anchors being configured to engage tissue of the biopsy site when the biopsy site marker is in the expanded state.
However, Levinson teaches that it is known to provide a marker with the marker element 10 (e.g., the clip 10 is made from radiopaque and reversibly compressible metals such as stainless steel or titanium, see par 0039, to a size smaller than 2-3 mm, see par 0076, so as to be visible under fluoroscopy) further including one or more anchors (30, 32) extending from the distal ends of the first portion 12 and the second portion 14 (see at least fig. 3A and par 0008, 0041-0043 & 0049).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the marker of Selis with the marker element further including one or more anchors extending from the distal ends of the first portion and the second portion, the one or more anchors being configured to engage tissue of the biopsy site when the biopsy site marker is in the expanded state as taught by Levinson since such a modification would amount to a simple substitution of one known element (i.e., the surgical clip of Selis) for another (i.e., the surgical clip of Levinson) to obtain predictable results such as providing a suitable surgical clip that expands upon deployment and includes a first portion connected to a second portion at an apex, wherein at least one of the first, second or both portions are straight, wherein said clips are generally configured to elastically deform to fit within a delivery device and subsequently return to an original shape upon exit as suggested by Selis (see at least par 0037 of Selis and par 0007-0010 & 0048 of Levinson)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 2, Selis discloses the marker of claim 1, that fails to explicitly teach a marker with the first and second portions forming a V- shape. However, Levinson teaches that it is known to provide a marker with the first and second portions (12, 14) forming a V- shape (see at least fig. 3A and par 0008, 0041-0043 & 0049). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the marker of Selis with the first and second portions forming a V- shape as taught by Levinson since such a modification would amount to a simple substitution of one known element (i.e., the surgical clip of Selis) for another (i.e., the surgical clip of Levinson) to obtain predictable results such as providing a suitable surgical clip that expands upon deployment and includes a first portion connected to a second portion at an apex, wherein at least one of the first, second or both portions are straight, wherein said clips are generally configured to elastically deform to fit within a delivery device and subsequently return to an original shape upon exit as suggested by Selis (see at least par 0037 of Selis and par 0007-0010 & 0048 of Levinson)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 3, Selis discloses the marker of claim 1, that fails to explicitly teach a marker with the one or more anchors including a first tine and a second tine, the first tine being joined to the first portion to extent outwardly from the first portion and the second tine being joined to the second portion to extend outwardly from the second portion. However, Levinson teaches that it is known to provide marker with the one or more anchors (30, 32) including a first tine 30 and a second tine 32, the first tine 30 being joined to the first portion 12 to extent outwardly from the first portion 12 and the second tine 32 being joined to the second portion 14 to extend outwardly from the second portion 14 (see at least fig. 3A and par 0008, 0041-0043 & 0049). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the marker of Selis with the one or more anchors including a first tine and a second tine, the first tine being joined to the first portion to extent outwardly from the first portion and the second tine being joined to the second portion to extend outwardly from the second portion as taught by Levinson since such a modification would amount to a simple substitution of one known element (i.e., the surgical clip of Selis) for another (i.e., the surgical clip of Levinson) to obtain predictable results such as providing a suitable surgical clip that expands upon deployment and includes a first portion connected to a second portion at an apex, wherein at least one of the first, second or both portions are straight, wherein said clips are generally configured to elastically deform to fit within a delivery device and subsequently return to an original shape upon exit as suggested by Selis (see at least par 0037 of Selis and par 0007-0010 & 0048 of Levinson)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 5, Selis discloses the marker of claim 1, that fails to explicitly teach a marker with the marker defining an acute angle between the first portion and the second portion. However, Levinson teaches that it is known to provide a marker, with the marker defining an acute angle between the first portion 12 and the second portion 14 (see at least fig. 3A and par 0008, 0041-0043 & 0049). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the marker of Selis with the marker defining an acute angle between the first portion and the second portion as taught by Levinson since such a modification would amount to a simple substitution of one known element (i.e., the surgical clip of Selis) for another (i.e., the surgical clip of Levinson) to obtain predictable results such as providing a suitable surgical clip that expands upon deployment and includes a first portion connected to a second portion at an apex, wherein at least one of the first, second or both portions are straight, wherein said clips are generally configured to elastically deform to fit within a delivery device and subsequently return to an original shape upon exit as suggested by Selis (see at least par 0037 of Selis and par 0007-0010 & 0048 of Levinson)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 6, Selis discloses the marker of claim 5, that fails to explicitly teach a marker with the marker being configured to be compressible such that the acute angle between the first portion and the second portion will become smaller when a force is applied inwardly to the first portion or the second portion. However, Levinson teaches that it is known to provide a marker with the marker being configured to be compressible such that the acute angle between the first portion 12 and the second portion 14 will become smaller when a force is applied inwardly to the first portion 12 or the second portion 14 (see at least fig. 3A and par 0008, 0041-0043 & 0049). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the marker of Selis with the marker being configured to be compressible such that the acute angle between the first portion and the second portion will become smaller when a force is applied inwardly to the first portion or the second portion as taught by Levinson since such a modification would amount to a simple substitution of one known element (i.e., the surgical clip of Selis) for another (i.e., the surgical clip of Levinson) to obtain predictable results such as providing a suitable surgical clip that expands upon deployment and includes a first portion connected to a second portion at an apex, wherein at least one of the first, second or both portions are straight, wherein said clips are generally configured to elastically deform to fit within a delivery device and subsequently return to an original shape upon exit as suggested by Selis (see at least par 0037 of Selis and par 0007-0010 & 0048 of Levinson)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 7, Selis discloses the marker of claim 6, that fails to explicitly teach a marker with the marker being configured to be expandable such that when the force is reduced or removed from the first portion or the second portion the acute angle between the first portion and the second portion becomes larger. However, Levinson teaches that it is known to provide a marker with the marker being configured to be expandable such that when the force is reduced or removed from the first portion 12 or the second portion 14, the acute angle between the first portion 12 and the second portion 14 becomes larger (see at least fig. 3A and par 0008, 0041-0043 & 0049). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the marker of Selis with the marker being configured to be expandable such that when the force is reduced or removed from the first portion or the second portion the acute angle between the first portion and the second portion becomes larger as taught by Levinson since such a modification would amount to a simple substitution of one known element (i.e., the surgical clip of Selis) for another (i.e., the surgical clip of Levinson) to obtain predictable results such as providing a suitable surgical clip that expands upon deployment and includes a first portion connected to a second portion at an apex, wherein at least one of the first, second or both portions are straight, wherein said clips are generally configured to elastically deform to fit within a delivery device and subsequently return to an original shape upon exit as suggested by Selis (see at least par 0037 of Selis and par 0007-0010 & 0048 of Levinson)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 8, Selis discloses the marker of claim 1, the marker being configured to be positioned in an outer cannula (e.g., needle 12 or delivery tube 16) in a compressed state (see at least figs. 3-4 and par 0023, 0028 & 0033-0036).
In regards to claim 9, Selis discloses the marker of claim 8, the marker being configured to transition from the compressed state to an expanded state when the marker 22 is deployed from the outer cannula (e.g., needle 12 or delivery tube 16) (see at least figs. 3-4 and par 0040-0043).
In regards to claim 10, Selis discloses the marker of claim 9, the marker being configured for deployment from the outer cannula (e.g., needle 12 or delivery tube 16) in the compressed state (see at least figs. 3-4 and par 0040-0043).
In regards to claim 11, Selis discloses the marker of claim 1, that fails to explicitly teach a marker with the marker element including a flat configuration defined by a sheet material being bent to form the first portion and the second portion of the marker element. However, Levinson teaches that it is known to provide a marker with the marker element 10 including a flat configuration (e.g., the flatness is better seen in figs. 1A-C & 2) defined by a sheet material being bent to form the first portion 12 and the second portion 14 of the marker element 10 (see at least fig. 3A). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the marker of Selis with the marker element including a flat configuration defined by a sheet material being bent to form the first portion and the second portion of the marker element as taught by Levinson since such a modification would amount to a simple substitution of one known element (i.e., the surgical clip of Selis) for another (i.e., the surgical clip of Levinson) to obtain predictable results such as providing a suitable surgical clip that expands upon deployment and includes a first portion connected to a second portion at an apex, wherein at least one of the first, second or both portions are straight, wherein said clips are generally configured to elastically deform to fit within a delivery device and subsequently return to an original shape upon exit as suggested by Selis (see at least par 0037 of Selis and par 0007-0010 & 0048 of Levinson)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claims 4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Selis (US 2005/0277871) in view of Levinson (US 2005/0277958) further in view of Vernon (EP 0432 692).
Selis as modified by Levinson discloses the marker of claim 1, that fails to explicitly teach a marker with the one or more anchors including one or more rough edges configured to increase the grip of the one or more anchors.
However, Vernon teaches that it is known to provide clip including one or more rough edges configured to increase the grip of the clip (see at least abstract, figs. col. 3, lines 35-50, col. 4, lines 30-58 and col. 5, lines 1-57).
Therefore, since both Selis and Levinson disclose surgical clips (see their respective abstracts), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the marker of Selis as modified by Levinson with the one or more anchors thereof including one or more rough edges configured to increase the grip, as taught by Vernon, of the one or more anchors thereof since such a modification would amount to applying a known technique (i.e., as taught by Vernon) to a known device (i.e., as taught by Selis/Levinson) ready for improvement to achieve a predictable result such as increasing the surface roughness or at least portions of the surgical clips by applying coatings of material thereon (see at least abstract of Vernon)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selis (US 2005/0277871) in view of Levinson (US 2005/0277958) further in view of Ahari et al. (US 2017/0231716) (“Ahari” hereinafter).
In regards to claim 14, Selis as modified by Levinson discloses the marker 10 of claim 1, that fails to explicitly teach a marker, the first marker material including collagen, the marker element including a second marker material, the second marker material including hydrogel. However, Ahari teaches that it is known to provide a marker 360, the first marker material 361 including collagen, the marker element (363, 364) including a second marker material 363, the second marker material including hydrogel (see at least abstract, fig. 7 and par 0067). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the marker of Selis as modified by Levinson with the first marker material including collagen, the marker element including a second marker material, the second marker material including hydrogel as taught by Ahari since such a modification would amount to applying a known technique (i.e., as taught by Ahari) to a known device (i.e., as taught by Jensen) ready for improvement to achieve a predictable result such as providing a marker body that is visible under ultrasound imaging, while marking element is visible under MRI, X-Ray, among other imaging modalities--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 15, Selis as modified by Levinson discloses the marker 10 of claim 1, that fails to explicitly teach a marker, the first marker material comprises hydrogel. However, Ahari teaches that it is known to provide a marker 360, the first marker material 362 comprises hydrogel 363 (see at least abstract, fig. 7 and par 0067). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the marker of Selis as modified by Levinson with the first marker material comprises hydrogel as taught by Ahari since such a modification would amount to applying a known technique (i.e., as taught by Ahari) to a known device (i.e., as taught by Jensen) ready for improvement to achieve a predictable result such as providing a marker body that is visible under ultrasound imaging, while marking element is visible under MRI, X-Ray, among other imaging modalities--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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/RENE T TOWA/ Primary Examiner, Art Unit 3791
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