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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “marker actuation element being configured to …” in claims 8 and 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The corresponding structure appears to be a push rod, as in claim 9.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 2 - 7, 11 - 12, and 14 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.
Claims 2, 3, 4, 5, and 14 are indefinite because there is insufficient antecedent basis for “the marker lumen”. It is unclear if the term is intended to refer to the “marking lumen”. For the purposes of examination, the term will be interpreted as referring to the “marking lumen”.
Claims 6 - 7 and 11 - 12 are indefinite by virtue of dependency.
Claim 14 is indefinite because there is insufficient antecedent basis for “the access port of the tissue sample holder”. The access port has not been set forth as being “of the tissue sample holder”. It is unclear if this is required.
Claim 14 is indefinite because there is insufficient antecedent basis for “the tissue sample holder”. It is unclear what is being referred to.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 - 4 and 8 - 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nock (US 2021/0282754).
Regarding claim 1, Nock shows a system for marking a biopsy site (abstract), the system comprising:
(a) a biopsy device (biopsy device, abstract), the biopsy device including:
(i) a body (i.e., the portion of the system proximal to biopsy needle 600),
(ii) a needle (biopsy needle 600, [0046] and figs. 5 - 8), the needle extending distally from the body (figs. 5 - 8), and including a tissue piercing tip (piercing tip 640, [0049] and figs. 6 - 7), the needle defining an axial lumen (upper cutter lumen 622, [0047] and fig. 8) and a lateral lumen (lower lateral lumen 624, [0047] and fig. 8), the axial lumen being configured to receive a cutter (tubular cutter 630, [0048] and fig. 8) therein, the tissue piercing tip defining a marking lumen (lumen 650, [0055] and figs. 6 - 8) in communication with the lateral lumen (650 communicates indirectly via openings 626); and
(b) a biopsy site marker (marker 100, [0024] - [0025] and figs. 1A - 1C; marker 300, [0034] and fig. 3), the biopsy site marker including a non-absorbable marker element (marker element 12 … “radiopaque or echogenic marker embedded within the bioabsorbable marker”, [0025] figs. 1A - 1C; “metallic, generally radiopaque permanent marker or marker element” 310, [0034] and fig. 3) and a bioabsorbable carrier (bioabsorbable carrier 120 in figs, 1A - 1C; carrier 306, [0034] and fig. 3), the marker element being at least partially disposed within the carrier (figs. 1A - 1C; fig. 3), the biopsy site marker being configured for receipt within the marking lumen of the needle (deployment of marker, [0074] and figs. 12B, 12C).
Regarding claim 2, Nock discloses the claimed invention substantially as noted above. Nock further shows the marker lumen (lumen 650, [0055] and figs. 6 - 8) extending through a planar surface defined by the tissue piercing tip (see figs. 6 - 8).
Regarding claim 3, Nock discloses the claimed invention substantially as noted above. Nock further shows the biopsy device further including the cutter (tubular cutter 630, [0048] and fig. 8), the needle further including an outer cannula (outer cannula 610, figs. 5 - 8), and a lateral aperture defined by a portion of the outer cannula (“outer cannula (610), lateral aperture (612) formed therein”, [0046] and figs. 5 - 8) the cutter being configured to move relative to the lateral aperture to sever one or more tissue samples (“Cutter (630) is then advanced distally to the position shown in FIG. 8 to sever a tissue sample”, [0048] and fig. 8), the marker lumen (lumen 650, [0055] and figs. 6 - 8) being laterally offset relative to a longitudinal axis defined by the cutter (see figs. 12A - 12C showing this arrangement).
Regarding claim 4, Nock discloses the claimed invention substantially as noted above. Nock further shows the biopsy device further including the cutter (tubular cutter 630, [0048] and fig. 8), the needle further including an outer cannula (outer cannula 610, figs. 5 - 8), and a lateral aperture defined by a portion of the outer cannula (“outer cannula (610), lateral aperture (612) formed therein”, [0046] and figs. 5 - 8) the cutter being configured to move relative to the lateral aperture to sever one or more tissue samples (“Cutter (630) is then advanced distally to the position shown in FIG. 8 to sever a tissue sample”, [0048] and fig. 8), the marker lumen (lumen 650, [0055] and figs. 6 - 8) being in communication with a portion of the lateral lumen (lower lateral lumen 624, [0047] and fig. 8) to define an axial deployment path laterally offset relative to the cutter, the axial deployment path extending from a distal end of the needle to a proximal end of the needle (see figs. 12A - 12C showing this arrangement).
Regarding claims 8 - 10, Nock discloses the claimed invention substantially as noted above. Nock further shows a marker actuation element including a push rod (push rod 718, [0064] and figs. 9 - 11) incorporated into the body (i.e., the portion of the system proximal to biopsy needle 600) of the biopsy device and configured to advance the biopsy site marker axially through the needle ([0074] - [0076]).
Regarding claim 11, Nock discloses the claimed invention substantially as noted above. Nock further shows a portion of the biopsy device defining an access port (proximal opening, [0059]) the access port being configured to communicate with the marking lumen of the needle (see figs. 12A - 12C).
Regarding claim 12, Nock discloses the claimed invention substantially as noted above. Nock further shows a portion of the biopsy device defining an access port (proximal opening, [0059]), the access port being configured to communicate with the marking lumen of the needle, the access port being configured to align with the lateral lumen of the needle to define a continuous path along an axis extending from the access port to the marking lumen (see figs. 12A - 12C).
Regarding claim 13, Nock discloses the claimed invention substantially as noted above. Nock further shows a tissue sample holder (“severed tissue sample can then be transported though cutter (630) and into a tissue sample holder or other tissue receiving feature under vacuum supplied by the biopsy device”, [0048]), the tissue sample holder being in communication with a portion of the needle. The tissue sample holder necessarily has an access port, as the samples pass through at least one opening to arrive at the tissue sample holder. The access port is configured to permit selective at least indirect communication with the marking lumen of the needle, lacking any further limiting details in the claim.
Regarding claim 14, Nock discloses the claimed invention substantially as noted above. Nock further shows the access port provides a substantially linear path to the
needle (see figs. 12A - 12C), which is interpreted as meeting the claim, as best understood in light of the clarity deficiencies noted above.
Regarding claim 15, Nock discloses the claimed invention substantially as noted above. Nock further shows an access tube, the access tube being in communication with one or more portions of the needle, the access tube being configured to permit communication of the biopsy site marker to the needle (marker delivery device 700, [0063] and figs. 9 - 11).
Regarding claim 16, Nock shows an apparatus for collecting a biopsy sample and marking tissue (abstract), the system comprising:
(a) a body (i.e., the portion of the system proximal to biopsy needle 600);
(b) a needle (biopsy needle 600, [0046] and figs. 5 - 8) extending distally from the body (figs. 5 - 12C), and including a tissue piercing tip (piercing tip 640, [0049] and figs. 6 - 7), an outer cannula (outer cannula 610, figs. 5 - 8), and a marker transport lumen (i.e., the interior lumen of outer cannula 610, figs. 12A - 12C) defined by a portion of the outer cannula, the marker transport lumen extending along the length of the outer cannula to the tissue piercing tip (figs. 12A - 12C), the outer cannula defining a lateral aperture (“outer cannula (610), lateral aperture (612) formed therein”, [0046] and figs. 5 - 8) proximate the tissue piercing tip;
(c) a cutter, the cutter being movable relative to the lateral aperture of the needle to sever one or more tissue samples (“Cutter (630) is then advanced distally to the position shown in FIG. 8 to sever a tissue sample”, [0048] and fig. 8);
(d) a tissue sample holder, the tissue sample holder being in communication with the needle to collect the one or more tissue samples from the needle (“severed tissue sample can then be transported though cutter (630) and into a tissue sample holder or other tissue receiving feature under vacuum supplied by the biopsy device”, [0048]); and
(b) a biopsy site marker (marker 100, [0024] - [0025] and figs. 1A - 1C; marker 300, [0034] and fig. 3), the biopsy site marker including a non-absorbable marker element (marker element 12 … “radiopaque or echogenic marker embedded within the bioabsorbable marker”, [0025] figs. 1A - 1C; “metallic, generally radiopaque permanent marker or marker element” 310, [0034] and fig. 3) and a bioabsorbable carrier (bioabsorbable carrier 120 in figs, 1A - 1C; carrier 306, [0034] and fig. 3), the marker element being at least partially disposed within the carrier (figs. 1A - 1C; fig. 3), the biopsy site marker being pre-loaded in the marker transport lumen prior to a biopsy procedure ([0072] - [0073], [0077]. Any surgical steps that take place after the marker is loaded in the marker transport lumen are interpreted as “a biopsy procedure”).
Regarding claim 17, Nock discloses the claimed invention substantially as noted above. Nock further shows the tissue piercing tip defining a marking lumen (lumen 650, [0055] and figs. 6 - 8), the marker lumen (lumen 650, [0055] and figs. 6 - 8) extending through a planar surface defined by the tissue piercing tip (see figs. 6 - 8), the marking lumen being in communication with the marker transport lumen (see figs. 12A - 12C).
Regarding claim 18, Nock discloses the claimed invention substantially as noted above. Nock further shows the tissue piercing tip defining a marking lumen (lumen 650, [0055] and figs. 6 - 8), the marker lumen (lumen 650, [0055] and figs. 6 - 8) extending through a planar surface defined by the tissue piercing tip (see figs. 6 - 8), the marking lumen being in communication with the marker transport lumen (see figs. 12A - 12C), the biopsy site marker being pre-loaded within the marker transport lumen at a position proximate the marking lumen (see figs. 12A - 12C).
Regarding claim 19, Nock discloses the claimed invention substantially as noted above. Nock further shows the marker transport lumen being laterally offset relative to a longitudinal axis defined by the cutter (see figs. 12A - 12C).
Regarding claim 20, Nock shows a method for deploying a biopsy site marker in tissue (abstract), the method comprising:
(a) obtaining a needle of a biopsy device (biopsy needle 600, [0046], figs. 5 - 8 and 12A - 12C), the needle having the biopsy site marker pre-loaded therein ([0072] - [0073], [0077]. The marker is necessarily pre-loaded before the marker is deployed);
(b) collecting one or more tissue samples (severed tissue sample, [0048]), using the needle of the biopsy device to form a biopsy site in the tissue (implicit);
(c) introducing a drive feature into the needle from a proximal end of the biopsy device to advance the biopsy site marker relative to the needle (“deployment is initiated by advancing push rod (718) distally using plunger (720) or a combination of plunger (720) and grip (716)”, [0074] - [0076] and figs. 12A - 12C); and
(d) deploying the biopsy site marker through a marker lumen defined by a distal tip of the needle using the drive feature (deployment, [0074] - [0076] and figs. 12A - 12C), the act of deploying the biopsy site marker including depositing the biopsy site marker at the biopsy site (“align distal opening (648) with the biopsy site”, [0073]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 - 7 are rejected under 35 U.S.C. 103 as being unpatentable over Nock in view of Vetter (2012/0109174).
Regarding claim 5, Nock discloses the claimed invention substantially as noted above. Nock further shows the biopsy device further including the cutter (tubular cutter 630, [0048] and fig. 8), the needle further including an outer cannula (outer cannula 610, figs. 5 - 8), and a lateral aperture defined by a portion of the outer cannula (“outer cannula (610), lateral aperture (612) formed therein”, [0046] and figs. 5 - 8), the cutter being configured to move relative to the lateral aperture to sever one or more tissue samples (“Cutter (630) is then advanced distally to the position shown in FIG. 8 to sever a tissue sample”, [0048] and fig. 8), the lateral lumen (lower lateral lumen 624, [0047] and fig. 8) comprising a vacuum lumen (“vacuum supplied though cutter lumen (622), lateral lumen (624), or both”, [0048]); and a marker transport lumen (internal lumen 715, [0067] and fig. 11), the marker lumen (lumen 650, [0055] and figs. 6 - 8) in communication with a portion of the marker transport lumen (internal lumen 715, [0067] and fig. 11), the vacuum lumen being in communication with a portion of the cutter (“vacuum supplied though cutter lumen (622), lateral lumen (624), or both”, [0048]).
Nock fails to show that an inner wall dividing the lateral lumen into the vacuum lumen and the marker transport lumen.
Vetter discloses tissue removing devices and methods. Vetter teaches an inner wall dividing a lateral lumen into a vacuum lumen and a marker transport lumen (“suction to draw tissue into the opening 132 …marker 102 housed in a marker storage area 136 …”, [0086] and inner wall dividing the vacuum region from the marker storage area in figs. 29 - 30).
It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Nock to include an inner wall dividing the lateral lumen into the vacuum lumen and the marker transport lumen, as taught by Vetter, in order to form the lumens as an integral structure, thereby optimizing manufacturing. It is noted that applicant discloses no criticality of the claimed feature.
Regarding claims 6 - 7, the combined invention of Nock and Vetter discloses the claimed invention substantially as noted above. Nock further shows the marker transport lumen (internal lumen 715, [0067] and fig. 11) being fluidly isolated from the axial lumen (upper cutter lumen 622, [0047] and fig. 8) and the vacuum lumen (“vacuum supplied … lateral lumen (624), or both”, [0048]) and disposed adjacent to the vacuum lumen (see figs. 12A - 12C showing 715 fluidly isolated from 622 and 624). Moreover, in the combined invention of the prior art, the vacuum lumen and marker transport lumen are divided by a sidewall, as discussed in the art rejection of claim 5, above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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