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 .
Election/Restrictions
Applicant’s election without traverse of Group I and Species B in the reply filed on 09/02/2026 is acknowledged.
Claim(s) 16-20 & 25 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/02/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show base portion as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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(s) 1-14 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1
Claim 1 recites, “base portion”. It isn’t clear what element is the base portion. The Drawings do not have a base portion labelled and the Specification fails to disclose further details. For the purpose of examination, it is assumed that the base portion is referring to a distal/proximal end of the marker.
Regarding Claim 5
Claim 5 recites, “three times or more”. However, it is not clear what this claim limitation is referring to. For the purpose of examination, it is assumed that the three times is referring to the size increasing three times or more.
Regarding Claim 9 & 10
Claims 9 & 10 recite, “the body portion”. It isn’t clear if this is a typo and the Applicant means to claim the base portion. For the purpose of examination, it is assumed that the claim limitation is meant to be base portion.
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.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sirimanne et al. (U.S. Patent 6,356,782 B1) and further in view of Fitz et al. (U.S. Patent 10,058,330 B2).
Claim 1: Sirimanne teaches –
A biopsy site marker [biopsy cavity-marking body] (Col. 2, Line 56), comprising:
a carrier [body members] (Figure 3B, Element 302),
the carrier being configured to expand in diameter in response to moisture [body members (302) may uniformly or in combination be made of one or more materials suitable for use in a biopsy cavity as previously described] (Col. 10, Line 20-24) [Each of the bodies depicted in FIGS. 1A-1E may be made from…expanding gelatinous bioabsorbable materials such as collagen] (Col. 8, Line 1-4); and
a marker element [marker] (Figure 3B, Element 322),
the marker element including a base portion (Figure 3B, Element 322, far right side of the marker, See pending 35 USC § 112 rejection above),
the base portion being disposed around an outer surface of the carrier (See Figure 3B),
the carrier being configured to drive movement of the marker element from the pre-deployment configuration to the post-deployment configuration [The expansion of the resilient body can be aided by the addition of a bio-compatible fluid which is absorbed into the body] (Col. 3, Line 48-50) [thereby aiding the expansion of the cavity marking device as it expands to fit the cavity] (Col. 3, Line 62-64) [the resiliency of the body causes the cavity marking device to self-expand, substantially filling the cavity] (Col. 3, Line 40-42)
Examiner’s Note: It is understood that Element 322 expands as Element 302 expands.
Sirimanne teaches various shapes to the marker element (Col. 11, Line 17-22). Sirimanne fails to teach interconnected legs. However, Fitz teaches –
the base portion [distal end portion] (Figure 1, Element 20) defining a plurality of interconnected legs [projecting elements] (Figure 1, Element 22) [protuberances] (Col. 3, Line 22),
each leg being configured to move relative to another leg to permit movement of the marker element from a pre-deployment configuration to a post-deployment configuration [a woven tubular support structure having a compressed configuration and an expanded configuration, wherein said woven tubular support structure is configured to self-expand to said expanded configuration] (Claim 1) in order to hold the base portion in place (Col. 3, Line 24-25) as movement of the imaging marker would affect the ability of the medical staff to return to the biopsy site at a later time
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 base portion of Sirimanne to the interconnected legs as taught by Fitz in order to hold the base portion in place (Col. 3, Line 24-25) as movement of the imaging marker would affect the ability of the medical staff to return to the biopsy site at a later time.
Claim 2/1: Sirimanne teaches the outer surface of the carrier defining a first diameter Sirimanne teaches, the base portion defining a second diameter (See Figure 3B, Element 322), the first diameter corresponding to the second diameter (Element 322 wraps around Element 302 and thus the diameters of the two elements are corresponding or in other words related).
Claim 3/1: Sirimanne teaches the outer surface of the carrier defining a first diameter Sirimanne teaches, the base portion defining a second diameter (See Figure 3B, Element 322), the second diameter being less than the first diameter to provide an interference fit between the carrier and the base portion (Element 322 wraps around Element 302 and thus provides an interference fit between the two).
Claim 4/2/1: Sirimanne teaches the carrier being configured to expand the second diameter defined by the base portion when driving movement of the marker element from the pre-deployment configuration to the post-deployment position [The expansion of the resilient body can be aided by the addition of a bio-compatible fluid which is absorbed into the body] (Col. 3, Line 48-50) [thereby aiding the expansion of the cavity marking device as it expands to fit the cavity] (Col. 3, Line 62-64) [the resiliency of the body causes the cavity marking device to self-expand, substantially filling the cavity] (Col. 3, Line 40-42).
Claim 5/2/1: Sirimanne teaches the carrier being configured to expand [marking device may be configured to be substantially smaller, larger, or equal to the size of the cavity] (Col. 5, Line 3-5) when driving movement of the marker element from the pre-deployment configuration to the post-deployment position [The expansion of the resilient body can be aided by the addition of a bio-compatible fluid which is absorbed into the body] (Col. 3, Line 48-50) [thereby aiding the expansion of the cavity marking device as it expands to fit the cavity] (Col. 3, Line 62-64) [the resiliency of the body causes the cavity marking device to self-expand, substantially filling the cavity] (Col. 3, Line 40-42).
Sirimanne fails to teach three times or more. However, Fitz teaches the carrier being configured to expand by three times or more [In a reduced or non-expanded state, the plug 12 preferably has a diameter of approximately 1 millimeter and a length of approximately 7 millimeters. In an expanded, unrestricted state…the plug 12 preferably has a diameter of approximately 4 millimeters] (Col. 4, Line 1-6) in order to hold the base portion in place (Col. 3, Line 24-25) as movement of the imaging marker would affect the ability of the medical staff to return to the biopsy site at a later time
Examiner’s Note: The diameter going from 1 millimeter to 4 millimeters would be 3 times or more increase in size.
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 base portion of Sirimanne to the interconnected legs as taught by Fitz in order to hold the base portion in place (Col. 3, Line 24-25) as movement of the imaging marker would affect the ability of the medical staff to return to the biopsy site at a later time.
Claim 6/1: Sirimanne teaches the marker element including a material, the material having at least some rigidity such that the base portion is configured to maintain a predetermined shape in absence of the carrier [the marker may be made of a non-bioabsorbable radiopaque material such as platinum, platinum-iridium, platinum-nickel, platinum-tungsten, gold, silver, rhodium, tungsten, tantalum, titanium, nickel, nickel-titanium, their alloys, and stainless steel or any combination of these metals].
Examiner’s Note: The metals are capable of at least some rigidity to maintain a predetermined shape.
Claim 7/1: Sirimanne teaches the carrier being bioabsorbable [bioabsorbable material] (Claim 1), the marker element being non-bioabsorbable [non-bioabsorbable material] (Claim 2).
Claim 8/1: Sirimanne teaches the carrier being configured to deform a shape during expansion of the carrier [expands to fit the cavity] (Col. 3, Line 63-65).
Sirimanne fails to teach legs. However, Fitz teaches defined by the plurality of legs [projecting elements] (Figure 1, Element 22) [protuberances] (Col. 3, Line 22) in order to hold the base portion in place (Col. 3, Line 24-25) as movement of the imaging marker would affect the ability of the medical staff to return to the biopsy site at a later time
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 base portion of Sirimanne to the interconnected legs as taught by Fitz in order to hold the base portion in place (Col. 3, Line 24-25) as movement of the imaging marker would affect the ability of the medical staff to return to the biopsy site at a later time.
Claim 9/1: Sirimanne teaches the carrier defining a cylindrical shape, the body portion of the marker element defining a shape corresponding to the carrier (See Figure 3B).
Claim 10/1: Sirimanne teaches the carrier defining a first axial length (Figure 3B, Element 320), the body portion of the marker element defining a second axial length (See Figure 3B, Element 322), the first axial length being longer than the second axial length (Compare Element 320 and 322 of Figure 3B).
Claim 11/1: Sirimanne teaches the base portion (Figure 3B, Element 322, far right side of the marker). Sirimanne fails to teach anchors. However, Firz teaches further including one or more anchors, each anchor of the one or more anchors extending outwardly from one or more legs of the plurality of legs [projecting elements 22 take the form of loops, hooks, protuberances, or staples, which tend to increase the friction between the frame and the lumen] (Col. 3, Line 21-24) in order to hold the base portion in place (Col. 3, Line 24-25) as movement of the imaging marker would affect the ability of the medical staff to return to the biopsy site at a later time
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 base portion of Sirimanne to the interconnected legs as taught by Fitz in order to hold the base portion in place (Col. 3, Line 24-25) as movement of the imaging marker would affect the ability of the medical staff to return to the biopsy site at a later time.
Claim 12/1: Sirimanne teaches the base portion (Figure 3B, Element 322, far right side of the marker). Sirimanne fails to teach anchors. However, Firz teaches further including one or more anchors, each anchor of the one or more anchors extending outwardly from one or more legs of the plurality of legs, each anchor of the one or more anchors being oriented at an angle relative to a longitudinal axis defined by the base portion [projecting elements 22 take the form of loops, hooks, protuberances, or staples, which tend to increase the friction between the frame and the lumen] (Col. 3, Line 21-24) in order to hold the base portion in place (Col. 3, Line 24-25) as movement of the imaging marker would affect the ability of the medical staff to return to the biopsy site at a later time
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 base portion of Sirimanne to the interconnected legs as taught by Fitz in order to hold the base portion in place (Col. 3, Line 24-25) as movement of the imaging marker would affect the ability of the medical staff to return to the biopsy site at a later time.
Claim 13/1: Sirimanne teaches the marker element including a surface treatment to one or more exterior surfaces of the marker element, the surface treatment being configured to increase echogenicity of the marker element [a coating or the like can be added to the marker to render the marker detectable or to enhance its detectability] (Col. 9, Line 33-35).
Claim 14/1: Sirimanne teaches the carrier including a collagen material [collagen] (Col. 8, Line 4).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Blair et al. (U.S. Patent Application 2021/0153972 A1) – Blair teaches composite markers employ a gel carrier to carry at least one radiopaque element (e.g., wire or band or clip) and one or more other contrast materials, each detectable by a detection modality different than one another.
Porter (U.S. Patent Application 2005/0090856 A1) – Porter teaches vaso-occlusive devices for occluding a body cavity include an internal element located within a lumen of the device. The internal element may comprise or otherwise include an agent carrier that comprises a bioactive material capable of eliciting a biological reaction after the device is placed in-situ. For example, the bioactive material can be a part of a composition of the agent carrier, absorbed by the agent carrier, or coated as a layer on the agent carrier.
Ranpura (U.S. Patent 8,311,610 B2) – Ranpura teaches a biopsy site marker includes a first marker element and a second marker element. The first marker element is configured for detection by a first imaging modality. The second marker element is configured for detection by a second imaging modality different from the first imaging modality. The second marker element may be a non-absorbable wire having a predetermined shape and is substantially engaged with the first marker element.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELENE C BOR whose telephone number is (571)272-2947. The examiner can normally be reached Mon - Fri 10:30 - 6:30.
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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
