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 .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 12/11/2024. The submission is 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 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 15 recites the limitation "the first wire portion" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the second wire portion" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 12-14, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahari (U.S. Pub. No. 20210220081) hereinafter Ahari.
Regarding claim 1, Ahari teaches:
A biopsy site marker (abstract), comprising:
a carrier ([0054]-[0058], bioabsorbable component 101 as in figures 1A-1B; [0061]-[0062]); and
a marker element including a base portion, a first anchor, and a second anchor ([0058]-[0059], beams 104a and 104b form a base portion as in figure 1A; [0063], anchoring arms 108a and 108b form first and second anchors as in figure 1A; [0065]-[0067]; [0070]-[0072]),
the base portion being at least partially disposed within the carrier ([0054]-[0058], portions 104a and 104b are at least partially disposed within the bioabsorbable component 101 as in figure 1A; [0059]; [0063]-[0065]),
at least a portion of the first anchor and the second anchor extending laterally and outwardly away from the base portion (As in figures 1A or 2B, anchoring arms 108a and 108b extend laterally and outwardly away from the base portion of 104a and 104b, [0054]-[0065]),
the first anchor and second anchor being configured to move relative to the base portion to engage tissue at a biopsy site ([0074]-[0077], as in figures 2A and 2B the spring enables the first and second anchors to move in a transition step relative to the base portion to an anchoring configuration for engagement with tissue at the site; [0088]),
the base portion defining a plurality of curved sections (figures 1A-1B and 2A-2B, springs 106a and 106b define curved portions that are part of the portions 104a and 104b (base portion) that defines a plurality of curved sections; [0063]-[0066]; [0072]; [0076]-[0077]) disposed between the first anchor, the second anchor and a curved proximal end portion ([0056]-[0059]; body section 102 is in the form of a coil and includes a curved portion which forms the curved proximal end portion in which the plurality of curved sections are disposed between this portion and the first and second anchors; figures 1A-1b and 2A-2B; [0063]-[0066]; [0072]; [0076]-[0077]), the plurality of curved sections being configured to define a distinct appearance under x-ray visualization ([0057], “body section 102 of non-bioabsorbable component 103 residing within bioabsorbable component 101. Body section 102 has a uniquely identifiable shape that (1) provides a means of ensuring that non-bioabsorbable component 103 cannot be easily removed from bioabsorbable component 101 comprised of soft material like hydrogel and (2) helps to easily identify biopsy marker 100 using imaging equipment”; [0064], “The variation in shapes of body sections 102 between different biopsy markers allows multiple biopsy markers to be inserted into a patient with each remaining visibly distinct when viewed through imaging equipment. For example, the coil shape, number of coils, orientation of the coil, size of the coil, size of the concentric circles of the coil, or spacing between circles within a coil can be adjusted to ensure that various biopsy markers can be differentiated from each other using imaging equipment. Likewise, different shapes of body section 102 between various biopsy markers can be used.”; see also [0058]-[0066]; [0072]-[0077]).
Regarding claim 2, Ahari teaches all of the limitations of claim 1. Ahari further teaches:
the first anchor and the second anchor extending laterally from the base portion at an angle relative to a longitudinal axis defined by the carrier (As in figures 1A or 2B, anchoring arms 108a and 108b extend laterally and outwardly away from the base portion of 104a and 104b at an angle relative to a longitudinal axis of the carrier 101, [0054]-[0065]).
Regarding claim 3, Ahari teaches all of the limitations of claim 2. Ahari further teaches:
the plurality of curved sections being oriented along the longitudinal axis defined by the carrier (figures 1A-1B and 2A-2B, springs 106a and 106b define curved portions that are part of the portions 104a and 104b (base portion) that defines a plurality of curved sections and are oriented along the longitudinal axis defined by the carrier; [0063]-[0066]; [0072]; [0076]-[0077]).
Regarding claim 4, Ahari teaches all of the limitations of claim 1. Ahari further teaches:
the carrier including a hydrogel marker material, the hydrogel marker material being configured to expand in the presence of moisture, the first anchor and second anchor being configured to respond to expansion of the hydrogel marker material to increase engagement of the first anchor and the second anchor with tissue ([0055], hydrogel as a bioabsorbable component 101; [0057]; [0074]; [0090]; [0091], expandability enables increased engagement with tissue by filling holes or voids in the tissue).
Regarding claim 5, Ahari teaches all of the limitations of claim 1. Ahari further teaches:
the first anchor and the second anchor each including an anchor member, the anchor member being disposed on an outer end of each of the first anchor and the second anchor ([0069]-[0071], scaffolding 110 of the anchor arms 108 forms anchor members disposed on the outer ends, figures 2A-2B; [0076]-[0080]; [0083]-[0087]).
Regarding claim 6, Ahari teaches all of the limitations of claim 5. Ahari further teaches:
the anchor member including one or more coils ([0069]-[0071], scaffolding 110 of the anchor arms 108 forms anchor members disposed on the outer ends, figures 2A-2B shown as coil shaped; [0076]-[0080]; [0083]-[0087]).
Regarding claim 7, Ahari teaches all of the limitations of claim 5. Ahari further teaches:
the anchor member defining a plurality of ridges ([0069]-[0071], scaffolding 110 of the anchor arms 108 forms anchor members disposed on the outer ends, figures 2A-2B shown as curved in a shape that forms ridges; [0076]-[0080]; [0083]-[0087]).
Regarding claim 8, Ahari teaches all of the limitations of claim 1. Ahari further teaches:
the base portion defining a helical portion extending from the proximal end portion to the first anchor and the second anchor, the helical portion defining the plurality of curved sections ([0057], body section 102 as in figures 1-2, includes a helical portion defining a plurality of curved sections at the proximal end portion and connected to first and second anchors; [0064], “The variation in shapes of body sections 102 between different biopsy markers allows multiple biopsy markers to be inserted into a patient with each remaining visibly distinct when viewed through imaging equipment. For example, the coil shape, number of coils, orientation of the coil, size of the coil, size of the concentric circles of the coil, or spacing between circles within a coil can be adjusted to ensure that various biopsy markers can be differentiated from each other using imaging equipment. Likewise, different shapes of body section 102 between various biopsy markers can be used.”; see also [0058]-[0066]; [0072]-[0077]).
Regarding claim 12, Ahari teaches all of the limitations of claim 1. Ahari further teaches:
the base portion defining a first wire portion and a second wire portion, the first wire portion and second wire portion being bent in opposite directions such that the first wire portion and the second wire portion cross one another at two or more points to define at least a portion of a curved section of the plurality of curved sections ([0058]-[0059], beams 104a and 104b form a base portion as in figure 1A and define a first wire and a second wire, bent in opposite directions at 106a and 106b and as in figures 1-2 cross over one another at two or more points to define the curved section in the folded state when in the deployment device; [0063]; [0065]-[0067]; [0070]-[0072]).
Regarding claim 13, Ahari teaches all of the limitations of claim 12. Ahari further teaches:
the first wire portion and the second wire portion each defining a straight section, the first wire portion and the second wire portion extending parallel to one another within the straight section ([0058]-[0059], beams 104a and 104b form a base portion as in figure 1A and define a first wire and a second wire, that each have a straight section extended parallel to one another; [0063]; [0065]-[0067]; [0070]-[0072]).
Regarding claim 14, Ahari teaches all of the limitations of claim 12. Ahari further teaches:
the first wire portion and the second wire portion being joined at the proximal end portion, the proximal end portion defining an end coil defining one or more wire loops ([0057], body section 102 as in figures 1-2, includes a helical portion defining a end coil with wire loops and at the proximal end portion where first and second wire portions are joined; [0064], “The variation in shapes of body sections 102 between different biopsy markers allows multiple biopsy markers to be inserted into a patient with each remaining visibly distinct when viewed through imaging equipment. For example, the coil shape, number of coils, orientation of the coil, size of the coil, size of the concentric circles of the coil, or spacing between circles within a coil can be adjusted to ensure that various biopsy markers can be differentiated from each other using imaging equipment. Likewise, different shapes of body section 102 between various biopsy markers can be used.”; see also [0058]-[0066]; [0072]-[0077]).
Regarding claim 16, Ahari teaches:
A biopsy site marker (abstract), the biopsy site marker comprising:
a carrier ([0054]-[0058], bioabsorbable component 101 as in figures 1A-1B; [0061]-[0062]); and
a marker element including a base portion, a first anchor, and a second anchor ([0058]-[0059], beams 104a and 104b form a base portion as in figure 1A; [0063], anchoring arms 108a and 108b form first and second anchors as in figure 1A; [0065]-[0067]; [0070]-[0072]),
the base portion being at least partially disposed within the carrier ([0054]-[0058], portions 104a and 104b are at least partially disposed within the bioabsorbable component 101 as in figure 1A; [0059]; [0063]-[0065]) and
defining a first wire and a second wire ([0058]-[0059], beams 104a and 104b form a base portion as in figure 1A and define a first wire and a second wire; [0063]; [0065]-[0067]; [0070]-[0072]),
at least a portion of the first anchor and the second anchor extending laterally and outwardly away from the base portion (As in figures 1A or 2B, anchoring arms 108a and 108b extend laterally and outwardly away from the base portion of 104a and 104b, [0054]-[0065]),
the first wire defining a first shaped section, the second wire defining a second shaped section, the first shaped section defining a helical shape extending along a longitudinal axis defined by the base portion (figures 1A-1B and 2A-2B, springs 106a and 106b define helical portions that are part of the portions 104a and 104b (base portion) that define the first wire and second wire with first and second shaped sections. 104a with 106a of the first shaped section defines the helical shape extended along a longitudinal axis defined by the base portion; [0063]-[0066]; [0072]; [0076]-[0077]).
Regarding claim 17, Ahari teaches all of the limitations of claim 16. Ahari further teaches:
the second shaped section of the second wire defining a shape corresponding to the first shaped section of the first wire (figures 1A-1B and 2A-2B, springs 106a and 106b define helical portions that are part of the portions 104a and 104b (base portion) that define the first wire and second wire with first and second shaped sections. The second shaped section thereby corresponds to the first shaped section shape; [0063]-[0066]; [0072]; [0076]-[0077]).
Regarding claim 18, Ahari teaches all of the limitations of claim 16. Ahari further teaches:
the second shaped section of the second wire defining a substantially linear shape (figures 1A-1B and 2A-2B, part of the portions 104b (base portion) that define the first wire and second wire with first and second shaped sections also define a substantially linear shape of the second shaped section of the second wire; [0063]-[0066]; [0072]; [0076]-[0077]).
Regarding claim 19, Ahari teaches all of the limitations of claim 16. Ahari further teaches:
the first wire being integral with the second wire ([0058]-[0059], beams 104a and 104b form a base portion as in figure 1A and define a first wire and a second wire which are integral with one another; [0063]; [0065]-[0067]; [0070]-[0072]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ahari as applied to claim 8 above, and further in view of Gifford, III et al. (U.S. Pub. No. 20180177486) hereinafter Gifford.
Regarding claim 9, primary reference Ahari teaches all of the limitations of claim 8. Primary reference Ahari further fails to teach:
the helical portion including two wire portions twisted together to form a double helix.
However, the analogous art of Gifford of an implantable device with marker and anchor elements (abstract) teaches:
the helical portion including two wire portions twisted together to form a double helix ([0107], anchor wires configured in a double helix shape; [0115]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tissue marker delivery system of Ahari to incorporate the double helix configuration of the wires as taught by Gifford because the double helix shape enables efficient collapsibility and expandability in both a deformed state within a delivery instrument and a deployed state in the tissue of interest (Gifford, [0107]; [0115]).
Regarding claim 10, the combined references of Ahari and Gifford teach all of the limitations of claim 9. Primary reference Ahari further teaches:
the two wire portions being integrally connected at the proximal end portion ([0056]-[0059]; body section 102 is in the form of a coil and is the proximal end portion that integrally connects the two wire portions; figures 1A-1b and 2A-2B; [0063]-[0066]; [0072]; [0076]-[0077]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ahari, in view of Gifford as applied to claim 9 above, and further in view of Hoyns et al. (U.S. Pat. No. 6766186) hereinafter Hoyns.
Regarding claim 11, the combined references of Ahari and Gifford teach all of the limitations of claim 9. Primary reference Ahari further fails to teach:
the two wire portions being separate discrete elements
However, the analogous art of Hoyns of an implant for marking a position of tissue (abstract) teaches:
the two wire portions being separate discrete elements (col 5, lines 46-67 and col 6, lines 1-15; figure 9-10 shows wires 41 and 42 as separate discreet elements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tissue marker delivery system of Ahari and Gifford to incorporate the separate discreet wire portions as taught by Hoyns because it provides multiple barb elements for anchoring to tissues of interest and can readily be joined through techniques such as welding, clamping, or adhesive bonding to form a secure connection (Hoyns, col 5, lines 46-67). This improves durability within the tissues.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ahari as applied to claim 1 above, and further in view of Hoyns.
Regarding claim 15, primary reference Ahari teaches all of the limitations of claim 1. Primary reference Ahari further teaches:
the first wire portion and the second wire portion extending from the first anchor and the second anchor toward the proximal end portion ([0058]-[0059], beams 104a and 104b form a base portion as in figure 1A and define a first wire and a second wire, that each have a straight section extended parallel to one another toward the proximal end portion; [0063]; [0065]-[0067]; [0070]-[0072]),
Primary reference Ahari further fails to teach:
the first wire portion and the second wire portion curving away from each other at the proximal end portion such that the first wire portion and the second wire portion are separate discrete elements
However, the analogous art of Hoyns of an implant for marking a position of tissue (abstract) teaches:
the first wire portion and the second wire portion curving away from each other at the proximal end portion such that the first wire portion and the second wire portion are separate discrete elements (col 5, lines 46-67 and col 6, lines 1-15; figure 9-10 shows wires 41 and 42 as separate discreet elements and are bent outwards from one another at the end portion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tissue marker delivery system of Ahari to incorporate the separate discreet bent wire portions as taught by Hoyns because it provides multiple barb elements for anchoring to tissues of interest and can readily be joined through techniques such as welding, clamping, or adhesive bonding to form a secure connection (Hoyns, col 5, lines 46-67). This improves durability within the tissues.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ahari, in view of Chudzik et al. (U.S. Pub. No. 20110144533) hereinafter Chudzik.
Regarding claim 20, primary reference Ahari teaches:
A kit for marking a biopsy site (abstract), the kit including:
(a) a marker delivery device ([0055], delivery device 202, figures 2A-2B; [0062]; [0067]; [0076]-[0077]), including:
(iii) a push rod being configured to translate within a portion of the marker lumen ([0077], plunger device 204 of figures 2A and 2B); and
(b) a plurality of markers, each marker of the plurality of markers being configured for receipt within the cannula of the marker delivery device for deployment through the marker port via the push rod ([0064], “include multiple biopsy markers”; [0076]-[0077], figures 2A-2B), each marker including:
(i) a carrier ([0054]-[0058], bioabsorbable component 101 as in figures 1A-1B; [0061]-[0062]), and
(ii) a marker element defining a base portion and one or more anchors ([0058]-[0059], beams 104a and 104b form a base portion as in figure 1A; [0063], anchoring arms 108a and 108b form first and second anchors as in figure 1A; [0065]-[0067]; [0070]-[0072]),
a portion of the marker element being disposed within at least a portion of the carrier ([0054]-[0058], portions 104a and 104b are at least partially disposed within the bioabsorbable component 101 as in figure 1A; [0059]; [0063]-[0065]),
the base portion of each marker element of the plurality of markers defining a distinct shape relative to each other base portion, at least one base portion defining a helical profile (figures 1A-1B and 2A-2B, springs 106a and 106b define helical portions that are part of the portions 104a and 104b (base portion) that define distinct shapes relative to each other. 104a/b with 106a/b of the first shaped section defines the helical shape extended along a longitudinal axis defined by the base portion; [0063]-[0066]; [0072]; [0076]-[0077]).
Primary reference Ahari fails to teach:
(i) a handpiece,
(ii) a cannula extending from the handpiece, the cannula defining a marker port, and
However, the analogous art of Chudzik of an introducer cannula device for delivery of a tissue anchor to a target region of interest (abstract) teaches:
(i) a handpiece ([0040], figure 3, handle 66 of marking apparatus 14),
(ii) a cannula extending from the handpiece, the cannula defining a marker port ([0040], figure 3, marker cannula 68 extending from the handpiece for providing a marker to tissue through the side port 76 which forms a marker port), and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tissue marker delivery system of Ahari to incorporate the handpiece and cannula with marker port as taught by Chudzik because the handle enables grasping by a user to provide the cannula to a particular target location of interest (Chudzik, [0040]). This leads to increased accuracy in deployment, and improved clinical outcomes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fisher et al. (U.S. Pat. No. 6994712) teaches to a clip and bioabsorbable marker that can be delivered to a tissue region of interest to mark a biopsy site.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 571-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN A FRITH/Primary Examiner, Art Unit 3798
Prosecution Insights